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Home / Drug Databases / OTC Monographs@FDA / Order Search / Order OTC000039

Proposed Order | Order Number OTC000039 | View Federal Register Notice ⬈

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Current order: Proposed Order

View FDA Supporting Documents

Document Name Document Type
Document Name Document Type
2025.12.09 ScientificReview_BemotrizinolOTC000039 Scientific Review
Document Name Document Type

View OMOR Supporting Documents

Section Document Name FDA Received Date
1.3 Administrative Information rev_03_213 Tinosorb S GLP-Report A_Redacted 05/05/2025
1.3 Administrative Information rev_09B031_FINAL_Redacted 01/16/2025
1.3 Administrative Information rev_09B031AM1_FINAL (1) 01/16/2025
1.2 Cover Letter rev_2020-0494 Inclusion-exclusion (1) 11/12/2024
1.2 Cover Letter rev_2020-0494 UV Dose (1) 11/12/2024
1.2 Cover Letter rev_2020-0495 Adverse Event (1)_Redacted 11/12/2024
1.2 Cover Letter rev_2020-0495 Discontinued Subjects (1)_Redacted 11/12/2024
1.2 Cover Letter rev_2020-0495 Inclusion-exclusion (1) 11/12/2024
1.2 Cover Letter rev_2020-0495 UV Dose (1) 11/12/2024
1.3 Administrative Information rev_2025 08 15_LoA for analytical report_BASF 08/21/2025
1.3 Administrative Information rev_2025 08 15_missing signature on analytical report_BASF 08/21/2025
1.3 Administrative Information rev_22288 - DSM PC2022-0231 587_Redacted 12/09/2024
1.3 Administrative Information rev_22289 - DSM PC2022-0231 964_Redacted 12/09/2024
1.3 Administrative Information rev_22290 - DSM PC2022-0231 520_Redacted 12/09/2024
1.3 Administrative Information rev_22291 - DSM PC2022-0231 005_Redacted 12/09/2024
1.3 Administrative Information rev_22292 - DSM PC2022-0231 321_Redacted 12/09/2024
1.3 Administrative Information rev_22293 - DSM PC2022-0231 031_Redacted 12/09/2024
1.3 Administrative Information rev_22294 - DSM PC2022-0231 782_Redacted 12/09/2024
1.3 Administrative Information rev_3-2-s-4-4-batch-analysis_corrected_Redacted 01/10/2025
1.3 Administrative Information rev_300721 Segment III rat Ota_2002b_appendicies 27-32 -part 2_Redacted 01/10/2025
1.3 Administrative Information rev_ADPC+ADPP+TPC1+TPC2+TPC3+TPP1+TPP3 11/12/2024
1.3 Administrative Information rev_ADPC+ADPP+TPC1+TPC2+TPC3+TPP1+TPP3 11/12/2024
1.3 Administrative Information rev_ADPC+ADPP+TPC1+TPC2+TPC3+TPP1+TPP3 11/12/2024
1.3 Administrative Information rev_ADPC+ADPP+TPC1+TPC2+TPC3+TPP1+TPP3 11/12/2024
1.3 Administrative Information rev_ADPC+ADPP+TPC1+TPC2+TPC3+TPP1+TPP3 11/12/2024
1.3 Administrative Information rev_ADPC+ADPP+TPC1+TPC2+TPC3+TPP1+TPP3 11/12/2024
1.3 Administrative Information rev_ADPC+ADPP+TPC1+TPC2+TPC3+TPP1+TPP3 11/12/2024
1.3 Administrative Information rev_ADPC+ADPP+TPC1+TPC2+TPC3+TPP1+TPP3 11/12/2024
1.2 Cover Letter rev_Appendix 1 Annotated_OTC_Monograph_M020_Bemotrizinol (1) 11/12/2024
1.3 Administrative Information rev_Attach 1_austprescr-41-50 01/31/2025
1.3 Administrative Information rev_Attach 2_DAEN Product Case Reports w MedDRA Reaction Terms_30-Jan-2025_025526 01/31/2025
1.3 Administrative Information rev_Attach 2_DAEN Product Case Reports w MedDRA Reaction Terms_30-Jan-2025_025526 (1) 09/04/2025
1.3 Administrative Information rev_Attach 3_DAEN Case Summary by MedDRA Reaction term and Organ Class_30-Jan-2025_022710 01/31/2025
1.3 Administrative Information rev_Attach 4_DAEN Product Case Reports w MedDRA reaction age less than 18_30-Jan-2025_040619 01/31/2025
1.3 Administrative Information rev_Attach 5_DAEN Case Summary by MedDRA Reaction term and Organ Class_ age less than 18_ 30-Jan-2025_030357 01/31/2025
1.3 Administrative Information rev_Attach 6_Categorized_DAEN_Reports_by SOC-PT 01/31/2025
1.3 Administrative Information rev_Attach 7_Tab_III_A_4_Bemotrizinol_Eye_irritation_rabbit_Redacted 01/31/2025
1.3 Administrative Information rev_attachement 1_HPLC_request 9_Redacted 12/09/2024
1.3 Administrative Information rev_attachement 2_HPLC_request 9_Redacted 12/09/2024
1.3 Administrative Information rev_attachement 3_HPLC_request 9_Redacted 12/09/2024
1.3 Administrative Information rev_attachment 4_structure_comparison_PARSOL Shield_USPreference_request 7_Redacted 12/09/2024
1.3 Administrative Information rev_Attachment 5_Redacted 12/09/2024
1.3 Administrative Information rev_attachment 6_Bemotrizinol by Region and Year in Sunbed Exposure_request 5 12/09/2024
1.3 Administrative Information rev_attachment 7_Units sold All_request 5 12/09/2024
1.3 Administrative Information rev_BE_HP-24-0683_01_P02_Redacted 12/09/2024
1.3 Administrative Information rev_BE_HP-24-0683_01_P03_Redacted 12/09/2024
1.3 Administrative Information rev_BE_HP-25-0307a_P01 (1)_Redacted 06/23/2025
1.3 Administrative Information rev_BE_HP-25-0307a_P01_Redacted 05/19/2025
1.3 Administrative Information rev_BE_HP-25-0307a_P02 (1)_Redacted 06/23/2025
1.3 Administrative Information rev_BE_HP-25-0307a_P02_Redacted 05/19/2025
1.3 Administrative Information rev_BE_HP-25-0307a_P03 (1)_Redacted 06/23/2025
1.3 Administrative Information rev_BE_HP-25-0307a_P03_Redacted 05/19/2025
1.3 Administrative Information rev_BE_HP-25-0307b_P01 (1)_Redacted 05/19/2025
1.3 Administrative Information rev_BE_HP-25-0307b_P01_Redacted 06/23/2025
1.3 Administrative Information rev_BE_HP-25-0307b_P02_Redacted 05/19/2025
1.3 Administrative Information rev_BE_HP-25-0307b_P02_Redacted 06/23/2025
1.3 Administrative Information rev_BE_HP-25-0307b_P03_Redacted 05/19/2025
1.3 Administrative Information rev_BE_HP-25-0307b_P03_Redacted 06/23/2025
1.3 Administrative Information rev_BE_HP_22-0682_01_P01_Redacted 12/09/2024
1.3 Administrative Information rev_BE_HP_22-0682_01_P02_Redacted 12/09/2024
1.3 Administrative Information rev_BE_HP_22-0682_01_P03_Redacted 12/09/2024
1.3 Administrative Information rev_BE_HP_22-0682_01_P04_Redacted 12/09/2024
1.3 Administrative Information rev_BE_HP_22-0683_01_P01_Redacted 12/09/2024
1.3 Administrative Information rev_Bemotrizinol_Sunscreen_DrugFacts_Label 05/12/2025
1.6.2 Meeting Background Materials rev_bemt-must-study-design_Redacted 09/23/2024
1.3 Administrative Information rev_bemt-usp 09/23/2024
1.3 Administrative Information rev_Certificate of Analysis_552 05/19/2025
1.3 Administrative Information rev_Certificate of Analysis_553 05/19/2025
1.3 Administrative Information rev_Certificate of Analysis_554 05/19/2025
1.3 Administrative Information rev_Certificate of Analysis_555 05/19/2025
1.6.3 Correspondence Regarding Meetings rev_correspondence-regarding-meetings 09/23/2024
1.2 Cover Letter rev_Cover Ltr MFG 400105 Final Response to Info Request filing com ltr (2) 01/16/2025
1.2 Cover Letter rev_Cover Ltr MFG 400105 Partial Response to Info Request filing com ltr (1)_Redacted 01/10/2025
1.2 Cover Letter rev_Cover Ltr MFG 400105 Response to Info Request 10_Redacted 02/03/2025
1.2 Cover Letter rev_Cover Ltr MFG 400105 Response to Info Request 11_Redacted 02/04/2025
1.2 Cover Letter rev_Cover Ltr MFG 400105 Response to Info Request 12 01/31/2025
1.2 Cover Letter rev_Cover Ltr MFG 400105 Response to Info Request 2_2781 (1) 10/18/2024
1.2 Cover Letter rev_Cover Ltr MFG 400105 Response to Info Request 3_2788_Part 2 (1)_Redacted 11/21/2024
1.2 Cover Letter rev_Cover Ltr MFG 400105 Response to Info Request 4_2807 (1) 10/28/2024
1.2 Cover Letter rev_Cover Ltr MFG 400105 Response to Info Request 5_2828 (1) 11/12/2024
1.2 Cover Letter rev_Cover Ltr MFG 400105 Response to Info Request 6 Final (1)_Redacted 12/09/2024
1.2 Cover Letter rev_Cover Ltr MFG 400105 Response to Info Request 7_3242 (1) 01/10/2025
1.2 Cover Letter rev_Cover Ltr MFG 400105 Response to Info Request 8 (1)_Redacted 01/10/2025
1.2 Cover Letter rev_Cover Ltr MFG 400105 Response to Info Request 9 (1) 01/15/2025
1.2 Cover Letter rev_Cover Ltr Response to MFG 400105 Info Request 14_3398_Final 03/28/2025
1.2 Cover Letter rev_Cover Ltr Response to MFG 400105 IR15_3622_Redacted 05/05/2025
1.2 Cover Letter rev_Cover Ltr Response to MFG 400105 IR16_3626 05/12/2025
1.2 Cover Letter rev_Cover Ltr Response to MFG 400105 IR18_3744_final 06/23/2025
1.2 Cover Letter rev_Cover Ltr Response to MFG 400105 IR19 08/21/2025
1.2 Cover Letter rev_Cover Ltr Response to MFG 400105 IR20_final_Redacted 08/21/2025
1.2 Cover Letter rev_Cover Ltr Response to MFG 400105 IR21Final 09/04/2025
1.2 Cover Letter rev_Cover Ltr Response to MFG 400105 IR22 09/22/2025
1.3 Administrative Information rev_cover-letter-type-c-meeting-package 09/23/2024
1.1 Table of Contents rev_ctd-toc 09/23/2024
1.3 Administrative Information rev_DAEN MedicinesBEMt AE SUMMARY 01/10/2025
1.2 Cover Letter rev_DSM 1572_HRIPT_CI_Poweski (1) 11/12/2024
1.2 Cover Letter rev_DSM 1572_PT_PA_Osis (1) 11/12/2024
1.2 Cover Letter rev_DSM Nutritional Products - Photoallergy - Final Protocol - Signed (1)_Redacted 11/12/2024
1.2 Cover Letter rev_DSM Nutritional Products - Phototoxicity - Final Protocol - Signed (2) 11/12/2024
1.2 Cover Letter rev_DSM Nutritional Products - RIPT and Cumulative Irritation - Final Protocol Signed (1) 11/12/2024
1.6.2 Meeting Background Materials rev_dsm-type-c-meeting-package_Redacted 09/23/2024
1.3 Administrative Information rev_EXCEL FILE NOT UPLOADED DUE TO LARGE FILE SIZE 08/21/2025
1.3 Administrative Information rev_EXCEL FILE NOT UPLOADED DUE TO LARGE FILE SIZE 08/21/2025
1.3 Administrative Information rev_EXCEL FILE NOT UPLOADED DUE TO LARGE FILE SIZE 08/21/2025
1.3 Administrative Information rev_EXCEL FILE NOT UPLOADED DUE TO LARGE FILE SIZE 08/21/2025
1.3 Administrative Information rev_EXCEL FILE NOT UPLOADED DUE TO LARGE FILE SIZE 08/21/2025
1.3 Administrative Information rev_EXCEL FILE NOT UPLOADED DUE TO LARGE FILE SIZE 08/21/2025
1.3 Administrative Information rev_EXCEL FILE NOT UPLOADED DUE TO LARGE FILE SIZE 08/21/2025
1.3 Administrative Information rev_F 125 Certifacte of Analysis_Redacted 02/04/2025
1.3 Administrative Information rev_fda-meeting-minutes-20190809 09/23/2024
1.3 Administrative Information rev_fda-meeting-request-granted-letter-20190129 09/23/2024
1.3 Administrative Information rev_fda-non-public-meeting-minutes-tc-20240607 09/23/2024
1.3 Administrative Information rev_fda-public-meeting-minutes-tc-20240607 09/23/2024
1.2 Cover Letter rev_Follow-up Cover Ltr Response to MFG 400105 Info Request 14_3398 04/02/2025
1.3 Administrative Information rev_Formulation composition in vivo SPF retest_2025_Redacted 05/19/2025
1.3 Administrative Information rev_GNPD download BEMT propellant sprays_table 1 09/22/2025
1.3 Administrative Information rev_gral-investigation-plan_Redacted 09/23/2024
1.3 Administrative Information rev_HP-22-0682_FDA_MEDu-initial_Redacted 12/09/2024
1.3 Administrative Information rev_HP-22-0682_RCEE 12/09/2024
1.3 Administrative Information rev_HP-22-0682_RCEE (1) 02/04/2025
1.3 Administrative Information rev_HP-22-0682_UV_dosing_series (1)_Redacted 02/04/2025
1.3 Administrative Information rev_HP-22-0683_FDA_MEDu-initial_Redacted 12/09/2024
1.3 Administrative Information rev_HP-22-0683_RCEE 12/09/2024
1.3 Administrative Information rev_HP-22-0683_RCEE (1) 02/04/2025
1.3 Administrative Information rev_HP-22-0683_UV_dosing_series_Redacted 02/04/2025
1.6.3 Correspondence Regarding Meetings rev_ind-146892-advice-information-request 09/23/2024
1.6.3 Correspondence Regarding Meetings rev_ind-146892-type-c-meeting-request-written-responses 09/23/2024
1.3 Administrative Information rev_ind146892-0000-correspondence 09/23/2024
1.3 Administrative Information rev_ind146892-0002-correspondence 09/23/2024
1.3 Administrative Information rev_ind146892-0003-correspondence 09/23/2024
1.3 Administrative Information rev_ind146892-0004-correspondence_Redacted 09/23/2024
1.3 Administrative Information rev_ind146892-0005-correspondence 09/23/2024
1.3 Administrative Information rev_ind146892-0006-correspondence 09/23/2024
1.3 Administrative Information rev_ind146892-0007-correspondence 09/23/2024
1.3 Administrative Information rev_ind146892-0008-correspondence 09/23/2024
1.3 Administrative Information rev_ind146892-0009-correspondence 09/23/2024
1.3 Administrative Information rev_ind146892-0010-correspondence 09/23/2024
1.3 Administrative Information rev_ind146892-0011-correspondence_Redacted 09/23/2024
1.3 Administrative Information rev_ind146892-0012-correspondence_Redacted 09/23/2024
1.3 Administrative Information rev_ind146892-0013-correspondence_Redacted 09/23/2024
1.3 Administrative Information rev_ind146892-cmc-advice-information-request-dec-24_Redacted 09/23/2024
1.3 Administrative Information rev_ind146892-cmc-advice-information-request-feb-24_Redacted 09/23/2024
1.3 Administrative Information rev_ind146892-cmc-advice-information-request-mar-24_Redacted 09/23/2024
1.3 Administrative Information rev_ind146892-fax 09/23/2024
1.3 Administrative Information rev_ind146892-study-may-proceed-letter_Redacted 09/23/2024
1.2 Cover Letter rev_Initial IRB Approval with Modifications Notice Feb0422 (1) 11/12/2024
1.14 Labeling rev_investigational-brochure_Redacted 09/23/2024
1.14 Labeling rev_labeling 09/23/2024
1.3 Administrative Information rev_List of products containing BEMT_propellants_raw data 09/22/2025
1.1 Table of Contents rev_m1-toc 09/23/2024
1.2 Cover Letter rev_Main ICF Pro00061070 Feb0422 11/12/2024
1.3 Administrative Information rev_Medicine Summary_04-Jan-2025_160805 1 BEMT AUSTRAILIA 1 01/10/2025
1.3 Administrative Information rev_Medicine Summary_04-Jan-2025_160805 1 BEMT AUSTRAILIA 2 01/10/2025
1.6.2 Meeting Background Materials rev_meeting-background-materials 09/23/2024
1.6.1 Meeting Request rev_meetings 09/23/2024
1.2 Cover Letter rev_MFG 400105 Cover ltr Info Request (1) 10/07/2024
1.3 Administrative Information rev_MFG 400105 Info Request on market data 10/07/2024
1.6.3 Correspondence Regarding Meetings rev_mgf-400083-revised-type-y-meeting-agenda-for-bemt 09/23/2024
1.6.3 Correspondence Regarding Meetings rev_mgf-400083-type-y-meeting-minutes_Redacted 09/23/2024
1.6.3 Correspondence Regarding Meetings rev_mgf-400083-type-y-meeting-package-cover-letter 09/23/2024
1.6.2 Meeting Background Materials rev_mgf-400083-type-y-meeting-package-part-1_Redacted 09/23/2024
1.6.2 Meeting Background Materials rev_mgf-400083-type-y-meeting-package-part-2_Redacted 09/23/2024
1.6.3 Correspondence Regarding Meetings rev_mgf-400083-type-y-meeting-preliminary-responses 09/23/2024
1.6.3 Correspondence Regarding Meetings rev_mgf-400083-type-y-meeting-request-granted 09/23/2024
1.6.2 Meeting Background Materials rev_mgf-400083-type-y-meeting-topics 09/23/2024
1.2 Cover Letter rev_Moy W - MD_updated CV 11142019 signed (1) 11/12/2024
1.2 Cover Letter rev_Osis G - Manager -2020 (1) 11/12/2024
1.3 Administrative Information rev_other-correspondence 09/23/2024
1.3 Administrative Information rev_P2 Reference Standard C of A - F089_Redacted 02/04/2025
1.3 Administrative Information rev_P2-Standard_2022-02-03_Redacted 02/04/2025
1.3 Administrative Information rev_PHPP-41-e70032 09/04/2025
1.3 Administrative Information rev_PI_SPF_Rev10 12/09/2024
1.3 Administrative Information rev_pind-146892-meeting-request-written-responses 09/23/2024
1.3 Administrative Information rev_pind-146892-submission-cover-letter 09/23/2024
1.3 Administrative Information rev_pind-correspondence 09/23/2024
1.2 Cover Letter rev_Poweski Cumulative ICF Pro00061064 Feb0622 (2) 11/12/2024
1.2 Cover Letter rev_Poweski RIPT ICF Pro00061064 Feb0422 (1) 11/12/2024
1.2 Cover Letter rev_Poweski S- Adv Clinic Manager 2020 (1) 11/12/2024
1.3 Administrative Information rev_PROTOCOL_HP-25-0307_Rev1 04/02/2025
1.3 Administrative Information rev_PROTOCOL_HP-25-0307a_Rev2 04/11/2025
1.3 Administrative Information rev_PROTOCOL_HP-25-0307a_Rev2_track changes 04/11/2025
1.3 Administrative Information rev_PROTOCOL_HP-25-0307b_Rev2 04/11/2025
1.2 Cover Letter rev_PT Initial IRB Approval with Modifications Notice Feb0422 (1) 11/12/2024
1.2 Cover Letter rev_PT Main ICF Pro00060762 Feb0422 (1)1 11/12/2024
1.4.1 Letter of Authorization rev_references_Redacted 09/23/2024
1.6.1 Meeting Request rev_request-for-type-c-meeting 09/23/2024
1.2 Cover Letter rev_Response to FDA 4-14-25 MGF 400105 advice ltr 04/16/2025
1.2 Cover Letter rev_RIPT CI IRB Initial Approval with Modifications Notice Feb0722 (1) 11/12/2024
1.3 Administrative Information rev_SCHRADER_M1 02/04/2025
1.3 Administrative Information rev_SCHRADER_M10 02/04/2025
1.3 Administrative Information rev_SCHRADER_M11 02/04/2025
1.3 Administrative Information rev_SCHRADER_M12 02/04/2025
1.3 Administrative Information rev_SCHRADER_M2 02/04/2025
1.3 Administrative Information rev_SCHRADER_M3 02/04/2025
1.3 Administrative Information rev_SCHRADER_M4 02/04/2025
1.3 Administrative Information rev_SCHRADER_M5 02/04/2025
1.3 Administrative Information rev_SCHRADER_M6 02/04/2025
1.3 Administrative Information rev_SCHRADER_M7 02/04/2025
1.3 Administrative Information rev_SCHRADER_M9 02/04/2025
1.2 Cover Letter rev_Second Follow-up Cover Ltr Response to MFG 400105 Info Request 14_3398 04/11/2025
1.2 Cover Letter rev_Study Requirements Letter CRLNJ2020-0493 2 (1) 11/12/2024
1.3 Administrative Information rev_SXXPA121PRT24120209140_Redacted 12/09/2024
1.3 Administrative Information rev_SXXPA121PRT24120209160_Redacted 12/09/2024
1.1 Table of Contents rev_Table of Contents - Response to FDA IR 2828 (1) 11/12/2024
1.2 Cover Letter rev_Table of Contents MFG 400105_Module 5 (1) 11/12/2024
1.2 Cover Letter rev_Third Follow-up Cover Ltr Response to MFG 400105 Info Request 14_3398_Redacted 05/19/2025
1.1 Table of Contents rev_TOC OMOR 400105 filing com IR final response (1) 01/16/2025
1.1 Table of Contents rev_TOC OMOR 400105 filing com IR response (1) 01/10/2025
1.1 Table of Contents rev_TOC OMOR 400105 IR11 02/04/2025
1.1 Table of Contents rev_TOC OMOR 400105 IR12 01/31/2025
1.1 Table of Contents rev_TOC OMOR 400105 IR120_3870 09/04/2025
1.1 Table of Contents rev_TOC OMOR 400105 IR121_3929 09/22/2025
1.1 Table of Contents rev_TOC OMOR 400105 IR14 2nd follow-up 04/11/2025
1.1 Table of Contents rev_TOC OMOR 400105 IR14 3rd follow-up_3398 05/19/2025
1.1 Table of Contents rev_TOC OMOR 400105 IR14 follow-up 04/02/2025
1.1 Table of Contents rev_TOC OMOR 400105 IR15 05/05/2025
1.1 Table of Contents rev_TOC OMOR 400105 IR16 05/12/2025
1.1 Table of Contents rev_TOC OMOR 400105 IR18_3744 06/23/2025
1.1 Table of Contents rev_TOC OMOR 400105 IR19_3831 08/21/2025
1.1 Table of Contents rev_TOC OMOR 400105 IR19_3831 08/21/2025
1.1 Table of Contents rev_TOC OMOR 400105 IR6 2855 (1) 12/09/2024
1.1 Table of Contents rev_TOC OMOR 400105 IR8 (1) 01/10/2025
1.1 Table of Contents rev_TOC Response to MFG 40015 IR7_3242 (1) 01/10/2025
1.3 Administrative Information rev_USP BEMT Proposed (1) 01/16/2025
1.3 Administrative Information rev_waiver-request 09/23/2024
1.3 Administrative Information rev2_admin-info_Redacted 09/23/2024
1.3 Administrative Information rev2_Annex I RAC Opinion on EHT_Redacted 06/27/2025
1.2 Cover Letter rev2_Appendix 1 (1)_Redacted 11/07/2024
1.2 Cover Letter rev2_Appendix 1. Confidential detailed calculation for EEC-soil South Region (2)_Redacted 11/21/2024
1.3 Administrative Information rev2_Appendix 1. Confidential_detailed calculation EIC aquatic_Redacted 02/21/2025
1.3 Administrative Information rev2_Appendix 1_QPRF_Redacted 02/14/2025
1.2 Cover Letter rev2_Appendix 2 (1)_Redacted 11/07/2024
1.2 Cover Letter rev2_Appendix 2. Confidential_ Modelling direct release scenario of BEMT into auqtic environment (1)_Redacted 11/21/2024
1.3 Administrative Information rev2_Appendix 2. Confidential_detailed calculation EIC and EEC soil_Redacted 02/21/2025
1.3 Administrative Information rev2_Appendix 2_QMRF_Redacted 02/14/2025
1.2 Cover Letter rev2_Appendix 3 (1)_Redacted 11/07/2024
1.3 Administrative Information rev2_Appendix 3_Summary Scifinder BEMT analogs_Redacted 02/14/2025
1.2 Cover Letter rev2_Cover Ltr MFG 400105 Followup Response to Info Request 13_Redacted 02/21/2025
1.2 Cover Letter rev2_Cover Ltr MFG 400105 Response to Info Request 13_Final_Redacted 02/14/2025
1.2 Cover Letter rev2_Cover Ltr MFG 400105 Response to Info Request 3_2788_final (1)_Redacted 11/07/2024
1.2 Cover Letter rev2_Cover Ltr Prelim Response 10-01-25 OMOR IN-REVIEW Meeting-final_Redacted 10/03/2025
1.2 Cover Letter rev2_Cover Ltr Response to MFG 400105 IR17_3743_Redacted 06/27/2025
1.2 Cover Letter rev2_cover-letter_Redacted 09/23/2024
1.3 Administrative Information rev2_environmental-analysis_Redacted 09/23/2024
1.3 Administrative Information rev2_SXXPA121PRT25040214300_J_m2 eff 04/02/2025
1.1 Table of Contents rev2_TOC OMOR 400105 IR13 final_Redacted 02/21/2025
1.1 Table of Contents rev2_TOC OMOR 400105 IR13_Redacted 02/14/2025
1.1 Table of Contents rev2_TOC OMOR 400105 IR17_3743_Redacted 06/27/2025
Section Document Name FDA Received Date
2.6.2 Pharmacology Written Summary rev_2.6.2-pharmacology-written-sum 10/18/2024
2.3.A.1 Facilities and Equipment rev_appendices 09/23/2024
2.3.A.2 Adventitious Agents Safety Evaluation rev_appendices (1) 09/23/2024
2.3.A.3 Excipients rev_appendices (2) 09/23/2024
2.5 Clinical Overview rev_clinical-overview 09/23/2024
2.3.P Drug Product rev_drug-product_Redacted 09/23/2024
2.3.S Drug Substance rev_drug-substance_Redacted 09/23/2024
2.2 Introduction to the Summary Documents rev_introduction 09/23/2024
2.3.I Introduction rev_introduction (1) 09/23/2024
2.6.1 Introduction rev_introduction (2) 09/23/2024
2.7.5 References rev_literature-references 09/23/2024
2.1 Table of Contents rev_m2-toc 09/23/2024
2.4 Nonclinical Overview rev_nonclinical-overview 09/23/2024
2.6.5 Pharmacokinetic Tabulated Summary rev_pharmkin-tabulated-summary 09/23/2024
2.6.2 Pharmacology Written Summary rev_pharmkin-written-summary 09/23/2024
2.6.4 Pharmacokinetic Written Summary rev_pharmkin-written-summary 09/23/2024
2.3.R Regional Information rev_regional-information 09/23/2024
2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods rev_summary-biopharm 09/23/2024
2.7.2 Summary of Clinical Pharmacology Studies rev_summary-clin-pharm 09/23/2024
2.7.4 Summary of Clinical Safety rev_summary-clin-safety 09/23/2024
2.7.6 Synopses of Individual Studies rev_synopses-indiv-studies_Redacted 09/23/2024
2.6.7 Toxicology Tabulated Summary rev_toxicology-tabulated-summary 09/23/2024
2.6.6 Toxicology Written Summary rev_toxicology-written-summary 09/23/2024
2.7.3 Summary of Clinical Efficacy rev2_summary-clin-efficacy-sunburn_Redacted 09/23/2024
Section Document Name FDA Received Date
3.2.P.4.2 Analytical Procedures rev_analytical-procedures 09/27/2024
3.2.P.4.2 Analytical Procedures rev_analytical-procedures (1) 09/27/2024
3.2.P.5.2 Analytical Procedures rev_analytical-procedures (10)_Redacted 09/27/2024
3.2.P.5.2 Analytical Procedures rev_analytical-procedures (11)_Redacted 09/27/2024
3.2.P.5.2 Analytical Procedures rev_analytical-procedures (12)_Redacted 09/27/2024
3.2.P.4.2 Analytical Procedures rev_analytical-procedures (2) 09/27/2024
3.2.P.4.2 Analytical Procedures rev_analytical-procedures (3) 09/27/2024
3.2.P.4.2 Analytical Procedures rev_analytical-procedures (4) 09/27/2024
3.2.P.4.2 Analytical Procedures rev_analytical-procedures (5) 09/27/2024
3.2.S.4.2 Analytical Procedures rev_analytical-procedures (6)_Redacted 09/27/2024
3.2.P.5.2 Analytical Procedures rev_analytical-procedures (7)_Redacted 09/27/2024
3.2.P.5.2 Analytical Procedures rev_analytical-procedures (8)_Redacted 09/27/2024
3.2.P.5.2 Analytical Procedures rev_analytical-procedures (9)_Redacted 09/27/2024
3.2.P.5.4 Batch Analyses rev_batch-analyses (1)_Redacted 09/27/2024
3.2.P.5.4 Batch Analyses rev_batch-analyses (2)_Redacted 09/27/2024
3.2.P.5.4 Batch Analyses rev_batch-analyses (3)_Redacted 09/27/2024
3.2.P.5.4 Batch Analyses rev_batch-analyses (4) 09/27/2024
3.2.P.5.4 Batch Analyses rev_batch-analyses (5) 09/27/2024
3.2.P.5.4 Batch Analyses rev_batch-analyses (6) 09/27/2024
3.2.S.4.4 Batch Analyses rev_batch-analyses_Redacted 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_batch-formula (1)_Redacted 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_batch-formula (2)_Redacted 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_batch-formula (3_Redacted 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_batch-formula (4)_Redacted 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_batch-formula (5)_Redacted 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_batch-formula_Redacted 09/27/2024
3.2.P.5.5 Characterization of Impurities rev_characterisation-impurities (1) 09/27/2024
3.2.P.5.5 Characterization of Impurities rev_characterisation-impurities (2) 09/27/2024
3.2.P.5.5 Characterization of Impurities rev_characterisation-impurities (3) 09/27/2024
3.2.P.5.5 Characterization of Impurities rev_characterisation-impurities (3) 09/27/2024
3.2.P.5.5 Characterization of Impurities rev_characterisation-impurities (4) 09/27/2024
3.2.P.5.5 Characterization of Impurities rev_characterisation-impurities_Redacted 09/27/2024
3.3 Literature References rev_cir-1985-lanette 09/27/2024
3.3 Literature References rev_cir-2008-alcohol 09/27/2024
3.3 Literature References rev_cir-2011-phenoxyethanol 09/27/2024
3.3 Literature References rev_cir-2012-finsolv 09/27/2024
3.3 Literature References rev_cir-2013-euxyl 09/27/2024
3.3 Literature References rev_cir-2015-isopropylmyristate 09/27/2024
3.3 Literature References rev_cir-2015-sodium-hydroxide 09/27/2024
3.3 Literature References rev_cir-2016-imwitor 09/27/2024
3.3 Literature References rev_cir-2016-keltrol 09/27/2024
3.3 Literature References rev_cir-2017-cetiol 09/27/2024
3.3 Literature References rev_cir-2018-magnesium-sulfate 09/27/2024
3.3 Literature References rev_cir-2018-myritol 09/27/2024
3.3 Literature References rev_cir-2019-amphisol 09/27/2024
3.3 Literature References rev_cir-2019-permulen 09/27/2024
3.3 Literature References rev_cir-2019-sunsolv 09/27/2024
3.3 Literature References rev_cir2019-magnesium-stearate 09/27/2024
3.3 Literature References rev_coa-amphisol_Redacted 09/27/2024
3.3 Literature References rev_coa-cetiol_Redacted 09/27/2024
3.3 Literature References rev_coa-cutina_Redacted 09/27/2024
3.3 Literature References rev_coa-dehymuls_Redacted 09/27/2024
3.3 Literature References rev_coa-ethanol_Redacted 09/27/2024
3.3 Literature References rev_coa-euxyl_Redacted 09/27/2024
3.3 Literature References rev_coa-finsolv_Redacted 09/27/2024
3.3 Literature References rev_coa-imwitor_Redacted 09/27/2024
3.3 Literature References rev_coa-isopropylmyristate_Redacted 09/27/2024
3.3 Literature References rev_coa-keltrol_Redacted 09/27/2024
3.3 Literature References rev_coa-lanette_Redacted 09/27/2024
3.3 Literature References rev_coa-magnesia_Redacted 09/27/2024
3.3 Literature References rev_coa-magnesium-sulphate_Redacted 09/27/2024
3.3 Literature References rev_coa-myritol_Redacted 09/27/2024
3.3 Literature References rev_coa-paracera_Redacted 09/27/2024
3.3 Literature References rev_coa-pemulen_Redacted 09/27/2024
3.3 Literature References rev_coa-sodium-hydroxide_Redacted 09/27/2024
3.3 Literature References rev_coa-sunsolv_Redacted 09/27/2024
3.3 Literature References rev_coa-vas-alb_Redacted 09/27/2024
3.3 Literature References rev_coa-x-tend_Redacted 09/27/2024
3.2.S.6 Container closure systems rev_container-closure-system 09/27/2024
3.2.P.7 Container closure system rev_container-closure-system (1) 09/27/2024
3.2.P.7 Container closure system rev_container-closure-system (2) 09/27/2024
3.2.P.7 Container closure system rev_container-closure-system (3) 09/27/2024
3.2.P.7 Container closure system rev_container-closure-system (4) 09/27/2024
3.2.P.7 Container closure system rev_container-closure-system (5) 09/27/2024
3.2.P.7 Container closure system rev_container-closure-system (6) 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_control-critical-steps (1)_Redacted 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_control-critical-steps (2)_Redacted 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_control-critical-steps (3)_Redacted 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_control-critical-steps (4) 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_control-critical-steps (5)_Redacted 09/27/2024
3.2.S.2.1 Manufacturer(s) rev_control-critical-steps (6)_Redacted 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_control-critical-steps_Redacted 09/27/2024
3.2.S.2.1 Manufacturer(s) rev_control-of-materials_Redacted 09/27/2024
3.2.P.1 Description and composition of the drug product rev_description-and-composition (2)_Redacted 09/27/2024
3.2.P.1 Description and composition of the drug product rev_description-and-composition (3)_Redacted 09/27/2024
3.2.P.1 Description and composition of the drug product rev_description-and-composition (4)_Redacted 09/27/2024
3.2.P.1 Description and composition of the drug product rev_description-and-composition (5)_Redacted 09/27/2024
3.2.P.1 Description and composition of the drug product rev_description-and-composition (6)_Redacted 09/27/2024
3.2.P.1 Description and composition of the drug product rev_description-and-composition_Redacted 09/27/2024
3.3 Literature References rev_echa-x-tend 09/27/2024
3.2.S.3.1 Elucidation of Structure and other Characteristics rev_elucidation-of-structure_Redacted 09/27/2024
3.2.P.4.5 Excipients of Human or Animal Origin rev_excipients-human-animal 09/27/2024
3.2.P.4.5 Excipients of Human or Animal Origin rev_excipients-human-animal (1) 09/27/2024
3.2.P.4.5 Excipients of Human or Animal Origin rev_excipients-human-animal (2) 09/27/2024
3.2.P.4.5 Excipients of Human or Animal Origin rev_excipients-human-animal (3) 09/27/2024
3.2.P.4.5 Excipients of Human or Animal Origin rev_excipients-human-animal (5) 09/27/2024
3.2.P.4.5 Excipients of Human or Animal Origin rev_excipients-human-animal (6) 09/27/2024
3.2.S.1 General information rev_general-properties 09/27/2024
3.2.S.1 General information rev_general-properties (1) 09/27/2024
3.2.S.3.2 Impurities rev_impurities_Redacted 09/27/2024
3.2.S.4.5 Justification of Specification rev_justification-of-specification 09/27/2024
3.2.P.5.6 Justification of Specification(s) rev_justification-of-specifications 09/27/2024
3.2.P.5.6 Justification of Specification(s) rev_justification-of-specifications (1) 09/27/2024
3.2.P.5.6 Justification of Specification(s) rev_justification-of-specifications (2) 09/27/2024
3.2.P.5.6 Justification of Specification(s) rev_justification-of-specifications (3) 09/27/2024
3.2.P.5.6 Justification of Specification(s) rev_justification-of-specifications (4) 09/27/2024
3.2.P.5.6 Justification of Specification(s) rev_justification-of-specifications (5) 09/27/2024
3.1 Table of Contents rev_m3-toc_Redacted 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_manuf-process-and-controls (1)_Redacted 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_manuf-process-and-controls (2)_Redacted 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_manuf-process-and-controls (3)_Redacted 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_manuf-process-and-controls (4)_Redacted 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_manuf-process-and-controls (5)_Redacted 09/27/2024
3.2.S.2.1 Manufacturer(s) rev_manuf-process-and-controls (6)_Redacted 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_manuf-process-and-controls_Redacted 09/27/2024
3.2.S.2.1 Manufacturer(s) rev_manuf-process-development 09/27/2024
3.2.S.2.1 Manufacturer(s) rev_manufacturer 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_manufacturers 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_manufacturers (1) 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_manufacturers (2) 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_manufacturers (3) 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_manufacturers (4) 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_manufacturers (5) 09/27/2024
3.3 Literature References rev_msds-amphisol 09/27/2024
3.3 Literature References rev_msds-cetiol 09/27/2024
3.3 Literature References rev_msds-cutina 09/27/2024
3.3 Literature References rev_msds-dehymuls 09/27/2024
3.3 Literature References rev_msds-ethanol 09/27/2024
3.3 Literature References rev_msds-euxyl 09/27/2024
3.3 Literature References rev_msds-finsolv 09/27/2024
3.3 Literature References rev_msds-imwitor 09/27/2024
3.3 Literature References rev_msds-isopropylmyristate 09/27/2024
3.3 Literature References rev_msds-keltrol 09/27/2024
3.3 Literature References rev_msds-lanette 09/27/2024
3.3 Literature References rev_msds-magnesia 09/27/2024
3.3 Literature References rev_msds-magnesium-sulphate 09/27/2024
3.3 Literature References rev_msds-myritol 09/27/2024
3.3 Literature References rev_msds-paracera 09/27/2024
3.3 Literature References rev_msds-parsol-shield 09/27/2024
3.3 Literature References rev_msds-pemulen 09/27/2024
3.3 Literature References rev_msds-sodium-hydroxide 09/27/2024
3.3 Literature References rev_msds-sunsolv 09/27/2024
3.3 Literature References rev_msds-vas-26750000 09/27/2024
3.3 Literature References rev_msds-x-tend 09/27/2024
3.3 Literature References rev_nicnas-2000-dehymuls 09/27/2024
3.2.S.1 General information rev_nomenclature 09/27/2024
3.2.S.1 General information rev_nomenclature (1) 09/27/2024
3.2.P.4.6 Novel Excipients rev_novel-excipients 09/27/2024
3.2.P.4.6 Novel Excipients rev_novel-excipients (1) 09/27/2024
3.2.P.4.6 Novel Excipients rev_novel-excipients (2) 09/27/2024
3.2.P.4.6 Novel Excipients rev_novel-excipients (3) 09/27/2024
3.2.P.4.6 Novel Excipients rev_novel-excipients (4) 09/27/2024
3.2.P.4.6 Novel Excipients rev_novel-excipients (5) 09/27/2024
3.2.P.2 Pharmaceutical development rev_pharmaceutical-development 09/27/2024
3.2.P.2 Pharmaceutical development rev_pharmaceutical-development (1) 09/27/2024
3.2.P.2 Pharmaceutical development rev_pharmaceutical-development (2) 09/27/2024
3.2.P.2 Pharmaceutical development rev_pharmaceutical-development (3) 09/27/2024
3.2.P.2 Pharmaceutical development rev_pharmaceutical-development (4) 09/27/2024
3.2.P.2 Pharmaceutical development rev_pharmaceutical-development (5) 09/27/2024
3.2.S.7.2 Post Approval Stability Protocol and Stability Commitment rev_postapproval-stability 09/27/2024
3.2.P.8.2 Post Approval Stability Protocol and Stability Commitment rev_postapproval-stability (1) 09/27/2024
3.2.P.8.2 Post Approval Stability Protocol and Stability Commitment rev_postapproval-stability (2) 09/27/2024
3.2.P.8.2 Post Approval Stability Protocol and Stability Commitment rev_postapproval-stability (3) 09/27/2024
3.2.P.8.2 Post Approval Stability Protocol and Stability Commitment rev_postapproval-stability (3) 09/27/2024
3.2.P.8.2 Post Approval Stability Protocol and Stability Commitment rev_postapproval-stability (4) 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_process-validation 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_process-validation (1) 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_process-validation (2)_Redacted 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_process-validation (3) 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_process-validation (4)_Redacted 09/27/2024
3.2.P.3.1 Manufacturer(s) rev_process-validation (5) 09/27/2024
3.2.S.5 Reference standards or materials rev_reference-standards 09/27/2024
3.2.P.6 Reference standards or materials rev_reference-standards (1) 09/27/2024
3.2.P.6 Reference standards or materials rev_reference-standards (2) 09/27/2024
3.2.P.6 Reference standards or materials rev_reference-standards (3) 09/27/2024
3.2.P.6 Reference standards or materials rev_reference-standards (4) 09/27/2024
3.2.P.6 Reference standards or materials rev_reference-standards (5) 09/27/2024
3.2.P.6 Reference standards or materials rev_reference-standards (6) 09/27/2024
3.2.R Regional Information rev_Regional Information 3.2.R 09/27/2024
3.2.S.4.1 Specification rev_specification_Redacted 09/27/2024
3.2.P.4.1 Specification(s) rev_specifications (1)_Redacted 09/27/2024
3.2.P.5.1 Specification(s) rev_specifications (10)_Redacted 09/27/2024
3.2.P.5.1 Specification(s) rev_specifications (11)_Redacted 09/27/2024
3.2.P.4.1 Specification(s) rev_specifications (2)_Redacted 09/27/2024
3.2.P.4.1 Specification(s) rev_specifications (3)_Redacted 09/27/2024
3.2.P.4.1 Specification(s) rev_specifications (4)_Redacted 09/27/2024
3.2.P.4.1 Specification(s) rev_specifications (5)_Redacted 09/27/2024
3.2.P.5.1 Specification(s) rev_specifications (6)_Redacted 09/27/2024
3.2.P.5.1 Specification(s) rev_specifications (7)_Redacted 09/27/2024
3.2.P.5.1 Specification(s) rev_specifications (8)_Redacted 09/27/2024
3.2.P.5.1 Specification(s) rev_specifications (9) 09/27/2024
3.2.P.4.1 Specification(s) rev_specifications_Redacted 09/27/2024
3.2.P.8.3 Stability Data rev_stability-data (1) 09/27/2024
3.2.P.8.3 Stability Data rev_stability-data (2) 09/27/2024
3.2.P.8.3 Stability Data rev_stability-data (3) 09/27/2024
3.2.P.8.3 Stability Data rev_stability-data (4) 09/27/2024
3.2.P.8.3 Stability Data rev_stability-data (5) 09/27/2024
3.2.S.7.3 Stability Data rev_stability-data_Redacted 09/27/2024
3.2.S.7.1 Stability Summary and Conclusions rev_stability-summary 09/27/2024
3.2.P.8.1 Stability Summary and Conclusion rev_stability-summary (1) 09/27/2024
3.2.P.8.1 Stability Summary and Conclusion rev_stability-summary (2) 09/27/2024
3.2.P.8.1 Stability Summary and Conclusion rev_stability-summary (3)_Redacted 09/27/2024
3.2.P.8.1 Stability Summary and Conclusion rev_stability-summary (4) 09/27/2024
3.2.P.8.1 Stability Summary and Conclusion rev_stability-summary (5) 09/27/2024
3.2.P.8.1 Stability Summary and Conclusion rev_stability-summary (6) 09/27/2024
3.2.S.1 General information rev_structure 09/27/2024
3.2.S.1 General information rev_structure (1) 09/27/2024
3.2.S.4.3 Validation of Analytical Procedures rev_val-analytical-procedures 09/27/2024
3.2.P.5.3 Validation of Analytical Procedures rev_val-analytical-procedures (1) 09/27/2024
3.2.P.5.3 Validation of Analytical Procedures rev_val-analytical-procedures (2)_Redacted 09/27/2024
3.2.P.5.3 Validation of Analytical Procedures rev_val-analytical-procedures (3) 09/27/2024
3.2.P.5.3 Validation of Analytical Procedures rev_val-analytical-procedures (4) 09/27/2024
3.2.P.5.3 Validation of Analytical Procedures rev_val-analytical-procedures (5) 09/27/2024
3.2.P.5.3 Validation of Analytical Procedures rev_val-analytical-procedures (6) 09/27/2024
3.2.S.2.1 Manufacturer(s) rev2_process-validation (6)_Redacted 09/27/2024
Section Document Name Study Type Secondary Study Type Tertiary Study Type Study ID Study Title Document Type FDA Received Date
4.1 Table of Contents rev_m4-toc 09/30/2024
4.2.2.1 Analytical methods and validation reports rev_00825015-report Pharmacokinetics Analytical methods and validation reports 00825015 Validation of an UHPLC-MS/MS Assay for the Determination of DNP-038124 Concentrations in Rat Plasma Assay validation 09/30/2024
4.2.2.1 Analytical methods and validation reports rev_00825013-amendment-1 Pharmacokinetics Analytical methods and validation reports 00825013 Validation of an UHPLC-MS/MS Assay for the Determination of DNP-038124 Concentrations in Mouse Plasma Assay validation 09/30/2024
4.2.2.1 Analytical methods and validation reports rev_00825013-report Pharmacokinetics Analytical methods and validation reports 00825013 Validation of an UHPLC-MS/MS Assay for the Determination of DNP-038124 Concentrations in Mouse Plasma Assay validation 09/30/2024
4.2.2.1 Analytical methods and validation reports rev_00825015-amendment-1 Pharmacokinetics Analytical methods and validation reports 00825015 Validation of an UHPLC-MS/MS Assay for the Determination of DNP-038124 Concentrations in Rat Plasma Assay validation 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825016 DNP-038124: A Single and Repeated Oral Dose Non-Radiolabeled Pharmacokinetic Study in Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_10b0377-21b110-report_Redacted Pharmacokinetics Absorption 10b0377-21b110 14C-BEMT in different cosmetic formulations Study of penetration through human skin in vitro Study report body 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825024 DNP-038124: A Single and 21-Day Repeated Dose Dermal Study in Wistar Han Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825024 DNP-038124: A Single and 21-Day Repeated Dose Dermal Study in Wistar Han Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825024 DNP-038124: A Single and 21-Day Repeated Dose Dermal Study in Wistar Han Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825024 DNP-038124: A Single and 21-Day Repeated Dose Dermal Study in Wistar Han Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_00825024-report Pharmacokinetics Absorption 00825024 DNP-038124: A Single and 21-Day Repeated Dose Dermal Study in Wistar Han Rats Study report body 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825024 DNP-038124: A Single and 21-Day Repeated Dose Dermal Study in Wistar Han Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825024 DNP-038124: A Single and 21-Day Repeated Dose Dermal Study in Wistar Han Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825024 DNP-038124: A Single and 21-Day Repeated Dose Dermal Study in Wistar Han Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825024 DNP-038124: A Single and 21-Day Repeated Dose Dermal Study in Wistar Han Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825024 DNP-038124: A Single and 21-Day Repeated Dose Dermal Study in Wistar Han Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825024 DNP-038124: A Single and 21-Day Repeated Dose Dermal Study in Wistar Han Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825024 DNP-038124: A Single and 21-Day Repeated Dose Dermal Study in Wistar Han Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825024 DNP-038124: A Single and 21-Day Repeated Dose Dermal Study in Wistar Han Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_ur0722-report_Redacted Pharmacokinetics Absorption UR0722 CGF-C1607: METABOLIC FATE FOLLOWING ORAL ADMINISTRATION IN RATS Study report body 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825016 DNP-038124: A Single and Repeated Oral Dose Non-Radiolabeled Pharmacokinetic Study in Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825016 DNP-038124: A Single and Repeated Oral Dose Non-Radiolabeled Pharmacokinetic Study in Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825016 DNP-038124: A Single and Repeated Oral Dose Non-Radiolabeled Pharmacokinetic Study in Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825016 DNP-038124: A Single and Repeated Oral Dose Non-Radiolabeled Pharmacokinetic Study in Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825016 DNP-038124: A Single and Repeated Oral Dose Non-Radiolabeled Pharmacokinetic Study in Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825016 DNP-038124: A Single and Repeated Oral Dose Non-Radiolabeled Pharmacokinetic Study in Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825016 DNP-038124: A Single and Repeated Oral Dose Non-Radiolabeled Pharmacokinetic Study in Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825016 DNP-038124: A Single and Repeated Oral Dose Non-Radiolabeled Pharmacokinetic Study in Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_20190089-report_Redacted Pharmacokinetics Absorption 20190089 DNP-038124 ��� In vitro Dermal Absorption of [14C]DNP-038124 in Different Cosmetic Formulations at a Concentration of 6% (w/w) on Human Skin Membranes Study report body 09/30/2024
4.2.2.2 Absorption rev_ur0698-report Pharmacokinetics Absorption UR0698 CGF-C1607: METABOLIC FATE FOLLOWING ORAL ADMINISTRATION IN RATS Study report body 09/30/2024
4.2.2.2 Absorption rev_20190090-report_Redacted Pharmacokinetics Absorption 20190090 DNP-038124 - In vitro Dermal Absorption of [14C]DNP-038124 in a Cosmetic Oil Formulation (SU E 101413 62) at a Concentration of 6% (w/w) on Rat Skin Membranes Study report body 09/30/2024
4.2.2.2 Absorption rev_csc-8-98-report_Redacted Pharmacokinetics Absorption CSC-8-98 IN VITRO HUMAN SKIN PENETRATION AND DISTRIBUTION OF THE UV ABSORBER CGF-C1607 Study report body 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825024 DNP-038124: A Single and 21-Day Repeated Dose Dermal Study in Wistar Han Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825024 DNP-038124: A Single and 21-Day Repeated Dose Dermal Study in Wistar Han Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825024 DNP-038124: A Single and 21-Day Repeated Dose Dermal Study in Wistar Han Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825024 DNP-038124: A Single and 21-Day Repeated Dose Dermal Study in Wistar Han Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825024 DNP-038124: A Single and 21-Day Repeated Dose Dermal Study in Wistar Han Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825016 DNP-038124: A Single and Repeated Oral Dose Non-Radiolabeled Pharmacokinetic Study in Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825016 DNP-038124: A Single and Repeated Oral Dose Non-Radiolabeled Pharmacokinetic Study in Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825016 DNP-038124: A Single and Repeated Oral Dose Non-Radiolabeled Pharmacokinetic Study in Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825016 DNP-038124: A Single and Repeated Oral Dose Non-Radiolabeled Pharmacokinetic Study in Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825016 DNP-038124: A Single and Repeated Oral Dose Non-Radiolabeled Pharmacokinetic Study in Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825016 DNP-038124: A Single and Repeated Oral Dose Non-Radiolabeled Pharmacokinetic Study in Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825016 DNP-038124: A Single and Repeated Oral Dose Non-Radiolabeled Pharmacokinetic Study in Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825016 DNP-038124: A Single and Repeated Oral Dose Non-Radiolabeled Pharmacokinetic Study in Rats Data tabulation dataset send 09/30/2024
4.2.2.2 Absorption rev_00825016-report Pharmacokinetics Absorption 00825016 DNP-038124: A Single and Repeated Oral Dose Non-Radiolabeled Pharmacokinetic Study in Rats Study report body 09/30/2024
4.2.2.2 Absorption rev_Datasets Pharmacokinetics Absorption 00825016 DNP-038124: A Single and Repeated Oral Dose Non-Radiolabeled Pharmacokinetic Study in Rats Data tabulation dataset send 09/30/2024
4.2.2.4 Metabolism rev_rd-00068522-report Pharmacokinetics Metabolism RD-00068522 In vitro investigations of the metabolic profile of Bemotrizinol by incubation of human hepatocytes and S9 fractions with 14C-Bemotrizinol Study report body 09/30/2024
4.2.3.1 Single dose toxicity rev_651407-report Toxicology Single dose toxicity 651407 Acute Oral Toxicity Study with CGF-C-1607 in Rats Study report body 09/30/2024
4.2.3.1 Single dose toxicity rev_651420-report Toxicology Single dose toxicity 651420 Acute Dermal Toxicity Study with CGF-C-1607 in Rats Study report body 10/01/2024
4.2.3.2 Repeat dose toxicity rev_Datasets Toxicology Repeat dose toxicity 20209876 A GLP 5-day and 28-day Study of DNP-038124 by Oral Gavage Administration in Mice Data tabulation dataset send 10/01/2024
4.2.3.2 Repeat dose toxicity rev_20209876-report_Redacted Toxicology Repeat dose toxicity 20209876 A GLP 5-day and 28-day Study of DNP-038124 by Oral Gavage Administration in Mice Study report body 10/01/2024
4.2.3.2 Repeat dose toxicity rev_Datasets Toxicology Repeat dose toxicity 20209876 A GLP 5-day and 28-day Study of DNP-038124 by Oral Gavage Administration in Mice Data tabulation dataset send 10/01/2024
4.2.3.2 Repeat dose toxicity rev_Datasets Toxicology Repeat dose toxicity 20209876 A GLP 5-day and 28-day Study of DNP-038124 by Oral Gavage Administration in Mice Data tabulation dataset send 10/01/2024
4.2.3.2 Repeat dose toxicity rev_Datasets Toxicology Repeat dose toxicity 20209876 A GLP 5-day and 28-day Study of DNP-038124 by Oral Gavage Administration in Mice Data tabulation dataset send 10/01/2024
4.2.3.2 Repeat dose toxicity rev_25378-tcr-report_Redacted Toxicology Repeat dose toxicity 25378-tcr 13-week Toxicity Study by Cutaneous Route in Rats Study report body 10/01/2024
4.2.3.2 Repeat dose toxicity rev_25455-tsr-report_Redacted Toxicology Repeat dose toxicity 25455-tsr Preliminary 2-Week Toxicity Study by Cutaneous Route in Rats Study report body 10/01/2024
4.2.3.2 Repeat dose toxicity rev_667541-report-part-3_Redacted Toxicology Repeat dose toxicity 667541 13 Week Oral Toxicity (Gavage) Study with CGF-C-1607/6 in the Rat Study report body 10/01/2024
4.2.3.2 Repeat dose toxicity rev_Datasets Toxicology Repeat dose toxicity 20209876 A GLP 5-day and 28-day Study of DNP-038124 by Oral Gavage Administration in Mice Data tabulation dataset send 10/01/2024
4.2.3.2 Repeat dose toxicity rev_Datasets Toxicology Repeat dose toxicity 20209876 A GLP 5-day and 28-day Study of DNP-038124 by Oral Gavage Administration in Mice Data tabulation dataset send 10/01/2024
4.2.3.2 Repeat dose toxicity rev_Datasets Toxicology Repeat dose toxicity 20209876 A GLP 5-day and 28-day Study of DNP-038124 by Oral Gavage Administration in Mice Data tabulation dataset send 10/01/2024
4.2.3.2 Repeat dose toxicity rev_667530-report_Redacted Toxicology Repeat dose toxicity 667530 14-Day Dose Range Finding (Gavage) Study with CGF-C-1607 in the Rat Study report body 10/01/2024
4.2.3.2 Repeat dose toxicity rev_Datasets Toxicology Repeat dose toxicity 20209876 A GLP 5-day and 28-day Study of DNP-038124 by Oral Gavage Administration in Mice Data tabulation dataset send 10/01/2024
4.2.3.2 Repeat dose toxicity rev_Datasets Toxicology Repeat dose toxicity 20209876 A GLP 5-day and 28-day Study of DNP-038124 by Oral Gavage Administration in Mice Data tabulation dataset send 10/01/2024
4.2.3.2 Repeat dose toxicity rev_Datasets Toxicology Repeat dose toxicity 20209876 A GLP 5-day and 28-day Study of DNP-038124 by Oral Gavage Administration in Mice Data tabulation dataset send 10/01/2024
4.2.3.2 Repeat dose toxicity rev_Datasets Toxicology Repeat dose toxicity 20209876 A GLP 5-day and 28-day Study of DNP-038124 by Oral Gavage Administration in Mice Data tabulation dataset send 10/01/2024
4.2.3.2 Repeat dose toxicity rev_Datasets Toxicology Repeat dose toxicity 20209876 A GLP 5-day and 28-day Study of DNP-038124 by Oral Gavage Administration in Mice Data tabulation dataset send 10/01/2024
4.2.3.2 Repeat dose toxicity rev_Datasets Toxicology Repeat dose toxicity 20209876 A GLP 5-day and 28-day Study of DNP-038124 by Oral Gavage Administration in Mice Data tabulation dataset send 10/01/2024
4.2.3.2 Repeat dose toxicity rev_Datasets Toxicology Repeat dose toxicity 20209876 A GLP 5-day and 28-day Study of DNP-038124 by Oral Gavage Administration in Mice Data tabulation dataset send 10/01/2024
4.2.3.2 Repeat dose toxicity rev_Datasets Toxicology Repeat dose toxicity 20209876 A GLP 5-day and 28-day Study of DNP-038124 by Oral Gavage Administration in Mice Data tabulation dataset send 10/01/2024
4.2.3.2 Repeat dose toxicity rev_Datasets Toxicology Repeat dose toxicity 20209876 A GLP 5-day and 28-day Study of DNP-038124 by Oral Gavage Administration in Mice Data tabulation dataset send 10/01/2024
4.2.3.2 Repeat dose toxicity rev_Datasets Toxicology Repeat dose toxicity 20209876 A GLP 5-day and 28-day Study of DNP-038124 by Oral Gavage Administration in Mice Data tabulation dataset send 10/01/2024
4.2.3.2 Repeat dose toxicity rev_25384-tcn-report (1)_Redacted Toxicology Repeat dose toxicity 25384-tcn 39 Week Toxicity Study by Cutaneous Route in Gottingen Minipigs Study report body 10/01/2024
4.2.3.2 Repeat dose toxicity rev_667541-report-part-1-2_Redacted Toxicology Repeat dose toxicity 667541 13 Week Oral Toxicity (Gavage) Study with CGF-C-1607/6 in the Rat Study report body 10/01/2024
4.2.3.2 Repeat dose toxicity rev_667541-protocol Toxicology Repeat dose toxicity 667541 13 Week Oral Toxicity (Gavage) Study with CGF-C-1607/6 in the Rat Protocol or amendment 10/01/2024
4.2.3.2 Repeat dose toxicity rev_25383-tsn-report_Redacted Toxicology Repeat dose toxicity 25383-tsn 2-Week Preliminary Toxicity Study by Cutaneous Route in Gottingen Minipigs Study report body 10/01/2024
4.2.3.2 Repeat dose toxicity rev_Datasets Toxicology Repeat dose toxicity 20209876 A GLP 5-day and 28-day Study of DNP-038124 by Oral Gavage Administration in Mice Data tabulation dataset send 10/01/2024
4.2.3.2 Repeat dose toxicity rev_Datasets Toxicology Repeat dose toxicity 20209876 A GLP 5-day and 28-day Study of DNP-038124 by Oral Gavage Administration in Mice Data tabulation dataset send 10/01/2024
4.2.3.2 Repeat dose toxicity rev_Datasets Toxicology Repeat dose toxicity 20209876 A GLP 5-day and 28-day Study of DNP-038124 by Oral Gavage Administration in Mice Data tabulation dataset send 10/01/2024
4.2.3.2 Repeat dose toxicity rev_Datasets Toxicology Repeat dose toxicity 20209876 A GLP 5-day and 28-day Study of DNP-038124 by Oral Gavage Administration in Mice Data tabulation dataset send 10/01/2024
4.2.3.3.1 In vitro rev_618300-report Toxicology Genotoxicity In vitro 618300 ESCHERICHIA COLi REVERSE MUTATION ASSAY WITH CGF-C-1607 Study report body 10/01/2024
4.2.3.3.1 In vitro rev_597700-report Toxicology Genotoxicity In vitro 597700 IN VITRO CHROMOSOME ABERRATION ASSAY IN CHINESE HAMSTER V79 CELLS WITH CGF-C-1607 Study report body 10/01/2024
4.2.3.3.1 In vitro rev_582800-report Toxicology Genotoxicity In vitro 582800 SALMONELLA TYPHIMURIUM REVERSE MUTATION ASSAY WITH CGF-C-1607 Study report body 10/01/2024
4.2.3.3.1 In vitro rev_512974-report Toxicology Genotoxicity In vitro 512974 EVALUATION OF THE MUTAGENIC ACTIVITY OF DNP-038124 IN THE SALMONELLA TYPHIMURIUM REVERSE MUTATION ASSAY AND THE ESCHERICHIA COLI REVERSE MUTATION ASSAY Study report body 10/01/2024
4.2.3.3.2 In vivo rev_fsr-ipl-040012-report (1) Toxicology Genotoxicity In vivo fsr-ipl-040012 MEASUREMENT OF UNSCHEDULED DNA SYNTHESIS (UDS) IN RAT HEPATOCYTES USING AN in vivo PROCEDURE WITH THE TEST COMPOUND FAT 70' 884/C Study report body 10/01/2024
4.2.3.3.2 In vivo rev_25608-mas-report (1) Toxicology Genotoxicity In vivo 25608-mas BONE MARROW MICRONUCLEUS TEST BY INTRAPERITONEAL ROUTE IN MICE Study report body 10/01/2024
4.2.3.4.1 Long term studies rev_25382-tcr-report-v6 Toxicology Carcinogenicity Long term studies 25382-tcr CARCINOGENICITY STUDY BY CUTANEOUS ROUTE IN RATS Study report body 10/01/2024
4.2.3.4.1 Long term studies rev_25382-tcr-report-v1_Redacted Toxicology Carcinogenicity Long term studies 25382-tcr CARCINOGENICITY STUDY BY CUTANEOUS ROUTE IN RATS Study report body 10/01/2024
4.2.3.4.1 Long term studies rev_25382-tcr-report-v5_Redacted Toxicology Carcinogenicity Long term studies 25382-tcr CARCINOGENICITY STUDY BY CUTANEOUS ROUTE IN RATS Study report body 10/01/2024
4.2.3.4.1 Long term studies rev_25382-tcr-report-v10_Redacted Toxicology Carcinogenicity Long term studies 25382-tcr CARCINOGENICITY STUDY BY CUTANEOUS ROUTE IN RATS Study report body 10/01/2024
4.2.3.4.1 Long term studies rev_25382-tcr-report-v4_Redacted Toxicology Carcinogenicity Long term studies 25382-tcr CARCINOGENICITY STUDY BY CUTANEOUS ROUTE IN RATS Study report body 10/01/2024
4.2.3.4.1 Long term studies rev_25382-tcr-report-v3_Redacted Toxicology Carcinogenicity Long term studies 25382-tcr CARCINOGENICITY STUDY BY CUTANEOUS ROUTE IN RATS Study report body 10/01/2024
4.2.3.4.1 Long term studies rev_25382-tcr-report-v12 Toxicology Carcinogenicity Long term studies 25382-tcr CARCINOGENICITY STUDY BY CUTANEOUS ROUTE IN RATS Study report body 10/01/2024
4.2.3.4.1 Long term studies rev_25382-tcr-report-v8_Redacted Toxicology Carcinogenicity Long term studies 25382-tcr CARCINOGENICITY STUDY BY CUTANEOUS ROUTE IN RATS Study report body 10/01/2024
4.2.3.4.1 Long term studies rev_25382-tcr-report-v7_Redacted Toxicology Carcinogenicity Long term studies 25382-tcr CARCINOGENICITY STUDY BY CUTANEOUS ROUTE IN RATS Study report body 10/01/2024
4.2.3.4.1 Long term studies rev_25382-tcr-report-v11_Redacted Toxicology Carcinogenicity Long term studies 25382-tcr CARCINOGENICITY STUDY BY CUTANEOUS ROUTE IN RATS Study report body 10/01/2024
4.2.3.4.1 Long term studies rev_25382-tcr-report-v9_Redacted Toxicology Carcinogenicity Long term studies 25382-tcr CARCINOGENICITY STUDY BY CUTANEOUS ROUTE IN RATS Study report body 10/01/2024
4.2.3.4.1 Long term studies rev_25382-tcr-report-v2_Redacted Toxicology Carcinogenicity Long term studies 25382-tcr CARCINOGENICITY STUDY BY CUTANEOUS ROUTE IN RATS Study report body 10/01/2024
4.2.3.5.1 Fertility and early embryonic development rev_100721-report_Redacted Toxicology Reproductive and developmental toxicity Fertility and early embryonic development 100721 Study for Effects of Oral Administration of RM-60 on Fertility and Early Embryonic Development to Implantation in Rats Study report body 10/01/2024
4.2.3.5.2 Embryofetal development rev_681491-report Toxicology Reproductive and developmental toxicity Embryofetal development 681491 Prenatal Toxicity Study with CGF-C-1607 in the Rat Study report body 10/01/2024
4.2.3.5.2 Embryofetal development rev_681480-report Toxicology Reproductive and developmental toxicity Embryofetal development 681480 Dose Range-Finding Prenatal Toxicity Study with CGF-C-1607/6 in the Rat Study report body 10/01/2024
4.2.3.5.2 Embryofetal development rev_203-014-report_Redacted Toxicology Reproductive and developmental toxicity Embryofetal development 203-014 ORAL (STOMACH TUBE) DEVELOPMENTAL TOXICITY STUDY OF TINOSORB S (FAT 70'884) IN RABBITS Study report body 10/01/2024
4.2.3.5.2 Embryofetal development rev_203-014p-pilot-report_Redacted Toxicology Reproductive and developmental toxicity Embryofetal development 203-014 ORAL (STOMACH TUBE) DEVELOPMENTAL TOXICITY STUDY OF TINOSORB S (FAT 70'884) IN RABBITS Study report body 10/01/2024
4.2.3.5.3 Prenatal and postnatal development, including maternal function rev_300721-report_Redacted Toxicology Reproductive and developmental toxicity Prenatal and postnatal development, including maternal function 300721 Study on Effects of Oral Administration of RM-60 on Pre- and Postnatal Development, Including Matemal Function, in Rats Study report body 10/01/2024
4.2.3.6 Local tolerance rev_512976-report Toxicology Local tolerance 512976 EVALUATION OF IN VITRO SKIN SENSITIZATION POTENTIAL OF DNP-038124 WITH THE KERATINOSENS��� ASSAY Study report body 10/01/2024
4.2.3.6 Local tolerance rev_512975-report Toxicology Local tolerance 512975 IN VITRO SKIN IRRITATION TEST WITH DNP-038124 USING A HUMAN SKIN MODEL Study report body 10/01/2024
4.2.3.6 Local tolerance rev_651453-report Toxicology Local tolerance 651453 Contact Hypersensitivity to CGF-C-1607 in Albino Guinea Pigs Maximization Test Study report body 10/01/2024
4.2.3.6 Local tolerance rev_651431-report Toxicology Local tolerance 651431 Primary Skin Irritation Study with CGF-C-1607 in Rabbits (4-hour occlusive application) Study report body 10/01/2024
4.2.3.6 Local tolerance rev_651442-report Toxicology Local tolerance 651442 Primary Eye Irritation Study with CGF-C-1607 in Rabbits Study report body 10/01/2024
4.2.3.6 Local tolerance rev_517122-report Toxicology Local tolerance 517122 In Chemico Determination of the Skin Sensitization Potential of DNP-038124 using the Direct Peptide Reactivity Assay (DPRA) Study report body 10/01/2024
4.2.3.7.3 Mechanistic studies rev_024530-report Toxicology Other toxicity studies Mechanistic studies 024530 CGF-C2089 and CGF-1607: Androgen Competitive Binding Assay Study report body 10/01/2024
4.2.3.7.3 Mechanistic studies rev_zr1601-report Toxicology Other toxicity studies Mechanistic studies zr1601 CGF-C1607: Uterotrophic Assay in Immature Rats Study report body 10/01/2024
4.2.3.7.3 Mechanistic studies rev_024529-report Toxicology Other toxicity studies Mechanistic studies 024529 CGF-C2089 and CGF-C1607: Estrogen Competitive Binding Assay Study report body 10/01/2024
4.2.3.7.5 Metabolites rev_meteor-nexus-report-plausible Toxicology Other toxicity studies Metabolites meteor-nexus-report-plausible Meteor Nexus Report CAS 187393-00-6: Meteor Nexus v.3.1.0, Plausible Study report body 10/01/2024
4.2.3.7.5 Metabolites rev_meteor-nexus-report-probable Toxicology Other toxicity studies Metabolites meteor-nexus-report-probable Meteor Nexus Report CAS 187393-00-6: Meteor Nexus v.3.1.0, Probable Study report body 10/01/2024
4.2.3.7.5 Metabolites rev_meteor-nexus-pathway Toxicology Other toxicity studies Metabolites meteor-nexus-pathway Bemotrizinol (PARSOL�� Shield CAS RN 187393-00-6): in silico Predicted Metabolism Pathway Meteor Nexus v.3.1.0, Probable Study report body 10/01/2024
4.2.3.7.7 Other rev_203-006-report_Redacted Toxicology Other toxicity studies Other 203-006 THIRTEEN-WEEK TOPICAL RANGE-FINDING STUDY OF TINOSORB M, TINOSORB MBBT AND TINOSORB S IN HAIRLESS MICE, WITH OR WITHOUT SIMULATED SUNLIGHT Study report body 10/01/2024
4.2.3.7.7 Other rev_203-018-report_Redacted Toxicology Other toxicity studies Other 203-018 TOPICAL EVALUATION OF THE PROTECTIVE POTENTIAL OF TINOSORB M, TINOSORB MBBT AND TINOSORB S AGAINST ULTRAVIOLET RADIATION (UVR) INDUCED CUTANEOUS INFLAMMATION IN HAIRLESS MICE: A SUN PROTECTION FACTOR (SPF)-LIKE EVALUATION Study report body 10/01/2024
4.2.3.7.7 Other rev_651497-report Toxicology Other toxicity studies Other 651497 Determination of Photoallergenicity with CGF-C-1607 in Albino Guinea Pigs (Including Information about Allergenicity, Photoirritation and Irritation Study report body 10/01/2024
4.2.3.7.7 Other rev_203-008-report_Redacted Toxicology Other toxicity studies Other 203-008 TWELVE-MONTH TOPICAL STUDY TO DETERMINE THE INFLUENCE OF TINOSORB S (FAT 70'884) ON PHOTOCARCINOGENESIS IN HAIRLESS MICE Study report body 10/01/2024
4.2.3.7.7 Other rev_609003-report Toxicology Other toxicity studies Other 609003 Photomutagenicity in a Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay with CGF-C-1607 Study report body 10/01/2024
4.2.3.7.7 Other rev_615904-report Toxicology Other toxicity studies Other 615904 Chromosome Aberration Assay In Vitro: Photomutagenicity in Hamster V79 Cells with CGF-C-1607 Study report body 10/01/2024
4.2.3.7.7 Other rev_651475-report Toxicology Other toxicity studies Other 651475 Determination of Phototoxicity with CGF-C-1607 in Albino Guinea Pigs Study report body 10/01/2024
4.2.3.7.7 Other rev_651475-report-addendum Toxicology Other toxicity studies Other 651475 Determination of Phototoxicity with CGF-C-1607 in Albino Guinea Pigs Study report body 10/01/2024
4.3 Literature References rev_safety-efficacy-data-docket-2005n-0446 09/30/2024
4.3 Literature References rev_opinion-sccnfp-0082-98 09/30/2024
Section Document Name Study Type Secondary Study Type Tertiary Study Type Study ID Study Title Document Type FDA Received Date
5.1 Table of Contents rev_m5-toc 09/30/2024
5.2 Tabular listing of all clinical studies rev_tabular-listing 09/30/2024
5.3.1.4 Reports of bioanalytical and analytical methods for human studies rev_00825020-report Reports of biopharmaceutic studies Reports of bioanalytical and analytical methods for human studies 00825020 Validation of an UHPLC-MS/MS Assay for the Determination of DNP-038124 Concentrations in Human Plasma -GLP Assay validation 09/30/2024
5.3.1.4 Reports of bioanalytical and analytical methods for human studies rev_00825023-report Reports of biopharmaceutic studies Reports of bioanalytical and analytical methods for human studies 00825023 Validation of an UHPLC-MS/MS Assay for the Determination of DNP-038124 Concentrations in K2EDTA Human Plasma (Low Range) Assay validation 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-16-4 Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Data listing dataset 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-16-1-6 Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 List patients with batches (E316.1.6) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-16-1-13_Redacted Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Other data not specified 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-16-2-4_Redacted Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Demographic data (E3 16.2.4) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-16-2-3 Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Patients excluded from efficacy analysis (E3 16.2.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-16-1-4 Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 List description investigator site (E3 16.1.4) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-16-1-5 Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Signatures investigators (E3 16.1.5) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-16-1-12 Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Publications referenced in report (E3 16.1.12) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-16-2-1 Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Discontinued patients (E3 16.2.1) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-16-1-8 Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Audit certificates report (E3 16.1.8) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-16-2-5 Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Compliance and drug concentration data (E3 16.2.5) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-16-1-1_Redacted Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Protocol or amendment (E3 16.1.1) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-report-synopsis Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Synopsis (ICH E3, section 2) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-16-2-8_Redacted Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Listing individual laboratory measurements by patient (E3 16.2.8) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-16-2-7 Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Adverse event listings (E3 16.2.7) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-body Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Study report body (E3 1, 3 to 15) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Protocol deviations (E3 16.2.2) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-16-2-6 Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Individual efficacy response data (E3 16.2.6) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-16-1-3_Redacted Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 IEC-IRB consent form list (E3 16.1.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-16-1-9 Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Statistical methods interim analysis plan (E3 16.1.9) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-16-1-10 Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Inter-laboratory standardisation methods quality assurance (E3 16.1.10) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-16-1-11 Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Publications based on study (E3 16.1.11) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-16-1-7 Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Randomisation scheme (E3 16.1.7) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_Case Report Forms Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Case report forms (E3 16.3) 09/30/2024
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information rev_bemt001-16-1-2 Reports of Human Pharmacokinetic (PK) Studies Healthy subject PK and initial tolerability Study reports and related information bemt-001 CLINICAL STUDY REPORT Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT) PROTOCOL NO. BEMT-001 Sample case report form (E3 16.1.2) 09/30/2024
5.3.5.1 Study reports and related information of controlled clinical studies pertinent to the claimed indication rev_dsm-pc2022-0231-report-sample-22290_Redacted Reports of Efficacy and Safety Studies Study reports and related information of controlled clinical studies pertinent to the claimed indication dsmpc2022-0231 sample 22290 Evaluation of a Sun Protection Product According to the FDA Document: Labelling and Effective Testing; Sunscreen Drug Products for Over-The-Counter Human Use; June 2011 Test Conditions: Static Eurofins Dermatest Sample Number: 22290 Client: DSM Nutritiona Study report body (E3 1, 3 to 15) 10/01/2024
5.3.5.1 Study reports and related information of controlled clinical studies pertinent to the claimed indication rev_dsm-pc2022-0231-report-sample-22288_Redacted Reports of Efficacy and Safety Studies Study reports and related information of controlled clinical studies pertinent to the claimed indication dsmpc2022-0231 sample 22288 Evaluation of a Sun Protection Product According to the FDA Document: Labelling and Effective Testing; Sunscreen Drug Products for Over-The-Counter Human Use; June 2011 Test Conditions: Static Eurofins Dermatest Sample Number: 22288 Client: DSM Nutritiona Study report body (E3 1, 3 to 15) 10/01/2024
5.3.5.1 Study reports and related information of controlled clinical studies pertinent to the claimed indication rev_dsm-pc2022-0231-report-sample-22289_Redacted Reports of Efficacy and Safety Studies Study reports and related information of controlled clinical studies pertinent to the claimed indication dsmpc2022-0231 sample 22289 Evaluation of a Sun Protection Product According to the FDA Document: Labelling and Effective Testing; Sunscreen Drug Products for Over-The-Counter Human Use; June 2011 Test Conditions: Static Eurofins Dermatest Sample Number: 22289 Client: DSM Nutritiona Study report body (E3 1, 3 to 15) 10/01/2024
5.3.5.1 Study reports and related information of controlled clinical studies pertinent to the claimed indication rev_hp-22-0682-report-product-01_Redacted Reports of Efficacy and Safety Studies Study reports and related information of controlled clinical studies pertinent to the claimed indication hp-22-0682 rpt -01 In Vivo Determination of Sun Protection Static Study report body (E3 1, 3 to 15) 10/01/2024
5.3.5.1 Study reports and related information of controlled clinical studies pertinent to the claimed indication rev_crlnj2020-0495-report_Redacted Reports of Efficacy and Safety Studies Study reports and related information of controlled clinical studies pertinent to the claimed indication crlnj2020-0495 Evaluation of Topically Applied Bemotrizinol for Human Photoallergic Potential Protocol Number DSM PA 2020 Study report body (E3 1, 3 to 15) 10/01/2024
5.3.5.1 Study reports and related information of controlled clinical studies pertinent to the claimed indication rev_crlnj2020-0495-ae Reports of Efficacy and Safety Studies Study reports and related information of controlled clinical studies pertinent to the claimed indication crlnj2020-0495 Evaluation of Topically Applied Bemotrizinol for Human Photoallergic Potential Protocol Number DSM PA 2020 Adverse event listings (E3 16.2.7) 10/01/2024
5.3.5.1 Study reports and related information of controlled clinical studies pertinent to the claimed indication rev_hp-22-0682-report-product-04_Redacted Reports of Efficacy and Safety Studies Study reports and related information of controlled clinical studies pertinent to the claimed indication hp22-0682 rpt -03 In Vivo Determination of Sun Protection Static Study report body (E3 1, 3 to 15) 10/01/2024
5.3.5.1 Study reports and related information of controlled clinical studies pertinent to the claimed indication rev_dsm-pc2022-0231-report-sample-22288_Redacted Reports of Efficacy and Safety Studies Study reports and related information of controlled clinical studies pertinent to the claimed indication dsmpc2022-0231 Evaluation of a Sun Protection Product According to the FDA Document: Labelling and Effective Testing; Sunscreen Drug Products for Over-The-Counter Human Use; June 2011 Test Conditions: Static Eurofins Dermatest Sample Number: 22288 Client: DSM Nutritiona Study report body (E3 1, 3 to 15) 10/01/2024
5.3.5.1 Study reports and related information of controlled clinical studies pertinent to the claimed indication rev_hp-22-0683-report-product-03_Redacted Reports of Efficacy and Safety Studies Study reports and related information of controlled clinical studies pertinent to the claimed indication hp-22-0683-rpt-03 In Vivo Determination of Sun Protection Static Study report body (E3 1, 3 to 15) 10/01/2024
5.3.5.1 Study reports and related information of controlled clinical studies pertinent to the claimed indication rev_crlnj2020-0493-report_Redacted Reports of Efficacy and Safety Studies Study reports and related information of controlled clinical studies pertinent to the claimed indication crlnj2020-0493 Evaluation of Bemotrizinol in Human Repeated Insult Patch Test (HRIPT) and Cumulative Irritation Test Protocol Number DSM RIPT 2020 Study report body (E3 1, 3 to 15) 10/01/2024
5.3.5.1 Study reports and related information of controlled clinical studies pertinent to the claimed indication rev_hp-22-0682-report-product-02_Redacted Reports of Efficacy and Safety Studies Study reports and related information of controlled clinical studies pertinent to the claimed indication hp-22-0682 rpt -02 In Vivo Determination of Sun Protection Static Study report body (E3 1, 3 to 15) 10/01/2024
5.3.5.1 Study reports and related information of controlled clinical studies pertinent to the claimed indication rev_hp-22-0682-report-product-03_Redacted Reports of Efficacy and Safety Studies Study reports and related information of controlled clinical studies pertinent to the claimed indication hp-22-0682 rpt -03 In Vivo Determination of Sun Protection Static Study report body (E3 1, 3 to 15) 10/01/2024
5.3.5.1 Study reports and related information of controlled clinical studies pertinent to the claimed indication rev_hp-22-0683-report-product-01_Redacted Reports of Efficacy and Safety Studies Study reports and related information of controlled clinical studies pertinent to the claimed indication hp-22-0683-rpt-01 In Vivo Determination of Sun Protection Static Study report body (E3 1, 3 to 15) 10/01/2024
5.3.5.1 Study reports and related information of controlled clinical studies pertinent to the claimed indication rev_crlnj2020-0494-report_Redacted Reports of Efficacy and Safety Studies Study reports and related information of controlled clinical studies pertinent to the claimed indication crlnj2020-0494 Evaluation of Topically Applied Bemotrizinol for Human Phototoxic Potential Protocol Number DSM PT 2020 Study report body (E3 1, 3 to 15) 10/01/2024
5.3.5.1 Study reports and related information of controlled clinical studies pertinent to the claimed indication rev_dsm-pc2022-0231-report-sample-22291_Redacted Reports of Efficacy and Safety Studies Study reports and related information of controlled clinical studies pertinent to the claimed indication dsmpc2022-0231 sample 22291 Evaluation of a Sun Protection Product According to the FDA Document: Labelling and Effective Testing; Sunscreen Drug Products for Over-The-Counter Human Use; June 2011 Test Conditions: Static Eurofins Dermatest Sample Number: 22291 Client: DSM Nutritiona Study report body (E3 1, 3 to 15) 10/01/2024
5.3.5.1 Study reports and related information of controlled clinical studies pertinent to the claimed indication rev_dsm-pc2022-0231-report-sample-22292_Redacted Reports of Efficacy and Safety Studies Study reports and related information of controlled clinical studies pertinent to the claimed indication dsmpc2022-0231 sample 22292 Evaluation of a Sun Protection Product According to the FDA Document: Labelling and Effective Testing; Sunscreen Drug Products for Over-The-Counter Human Use; June 2011 Test Conditions: Static Eurofins Dermatest Sample Number: 22292 Client: DSM Nutritiona Study report body (E3 1, 3 to 15) 10/01/2024
5.3.5.1 Study reports and related information of controlled clinical studies pertinent to the claimed indication rev_dsm-pc2022-0231-report-sample-22293_Redacted Reports of Efficacy and Safety Studies Study reports and related information of controlled clinical studies pertinent to the claimed indication dsmpc2022-0231 sample 22293 Evaluation of a Sun Protection Product According to the FDA Document: Labelling and Effective Testing; Sunscreen Drug Products for Over-The-Counter Human Use; June 2011 Test Conditions: Static Eurofins Dermatest Sample Number: 22293 Client: DSM Nutritiona Study report body (E3 1, 3 to 15) 10/01/2024
5.3.5.1 Study reports and related information of controlled clinical studies pertinent to the claimed indication rev_dsm-pc2022-0231-report-sample-22294_Redacted Reports of Efficacy and Safety Studies Study reports and related information of controlled clinical studies pertinent to the claimed indication dsmpc2022-0231 sample 22294 Evaluation of a Sun Protection Product According to the FDA Document: Labelling and Effective Testing; Sunscreen Drug Products for Over-The-Counter Human Use; June 2011 Test Conditions: Static Eurofins Dermatest Sample Number: 22294 Client: DSM Nutritiona Study report body (E3 1, 3 to 15) 10/01/2024
5.3.5.1 Study reports and related information of controlled clinical studies pertinent to the claimed indication rev_hp-22-0683-report-product-02_Redacted Reports of Efficacy and Safety Studies Study reports and related information of controlled clinical studies pertinent to the claimed indication hp-22-0683-rpt-02 In Vivo Determination of Sun Protection Static Study report body (E3 1, 3 to 15) 10/01/2024
5.3.6 Postmarketing periodic adverse event drug experience report description rev_tga-daen tga-daen Database of Adverse Event Notifications - medicines Medicine summary 10/01/2024
5.3.6 Postmarketing periodic adverse event drug experience report description rev_suzuki-2022 (1) suzuki-2022 Allergic contact dermatitis caused by dimethicodiethylbenzalmalonate (polysilicone-15, ���Parsol SLX) and bis-ethylhexyloxyphenol methoxyphenyl triazine (Tinosorb S) in sunscreen cream 10/01/2024
5.3.6 Postmarketing periodic adverse event drug experience report description rev_luna-bastante-2019 luna-bastante-2019 ALLERGIC CONTACT DERMATITIS TO TINOSORB S, SCUTELLARIA BAICALENSIS AS WELL AS OTHER EMERGING ALLERGENS IN COSMETICS 10/01/2024
5.4 Literature References rev_suzuki-2022 09/30/2024
5.4 Literature References rev_luna-bastante-2019 (1) 09/30/2024
5.4 Literature References rev_herzog-2004 09/30/2024
5.4 Literature References rev_htr-100243b_Redacted 09/30/2024
5.4 Literature References rev_htr-100243a_Redacted 09/30/2024
5.4 Literature References rev_d-ruiz-2023 09/30/2024
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