Scientific Publications by FDA Staff

Recent Scientific Publications

Animal and Veterinary

• Microorganisms 2019 Sep 6;7(9):325
  Effects of acute and chronic exposure to residual level erythromycin on human intestinal epithelium cell permeability and cytotoxicity.
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Biologics

• PLoS One 2019 Sep 6;14(9):e0221159
  Gender differences in innate responses and gene expression profiles in memory CD4 T cells are apparent very early during acute simian immunodeficiency virus infection.
• J Virol 2019 Sep 4 [Epub ahead of print]
  Lack of activation marker induction and chemokine receptor switch in human neonatal myeloid dendritic cells in response to human respiratory syncytial virus.
• PLoS One 2019 Aug 27;14(8):e0221711
  Identification of zinc and Zur-regulated genes in Corynebacterium diphtheriae.
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Drugs

• PLoS Med 2019 Sep 6;16(9):e1002915
  Development of new TB regimens: harmonizing trial design, product registration requirements, and public health guidance.
• J Clin Pharmacol 2019 Sep 6 [Epub ahead of print]
  Physiologically based pharmacokinetic models to predict maternal pharmacokinetics and fetal exposure to emtricitabine and acyclovir.
• J Biopharm Stat 2019 Sep 5 [Epub ahead of print]
  Non-inferiority tests for binary endpoints with variable margins.
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Food

• J AOAC Int 2019 May-Jun;102(3):926-35
  Validation of the Listeria Right Now(TM) test for detection of Listeria spp. from selected environmental surfaces without enrichment.
• J AOAC Int 2019 May-Jun;102(3):815-27
  Comparative validation study to demonstrate the equivalence of an alternate next-day enrichment protocol for VIP Gold((R)) for Salmonella method to culture methods for the detection of Salmonella in selected foods and environmental surfaces.
• J AOAC Int 2019 May-Jun;102(3):828-41
  Comparative validation study to demonstrate the equivalence of an alternate next-day enrichment protocol for the TRANSIA((R)) PLATE Salmonella gold method to culture methods for the detection of Salmonella in selected foods and environmental surfaces.
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Medical Devices

• Environ Mol Mutagen 2019 Aug 30 [Epub ahead of print]
  Rationale and roadmap for developing panels of hotspot cancer driver gene mutations as biomarkers of cancer risk.
• Magn Reson Med 2019 Aug 29 [Epub ahead of print]
  Wire-based sternal closure: MRI-related heating at 1.5 T/64 MHz and 3 T/128 MHz based on simulation and experimental phantom study.
• J Ophthalmol 2019 Aug 4;2019:7929014
  Quantitative multiparameter evaluation of vacuoles in intraocular lenses employing a high-magnification digital microscopy method.
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Office of the Commissioner

• J Clin Pharmacol 2019 Sep 6 [Epub ahead of print]
  Physiologically based pharmacokinetic models to predict maternal pharmacokinetics and fetal exposure to emtricitabine and acyclovir.
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Regulatory Affairs

• Food Addit Contam Part A 2019 Sep 3 [Epub ahead of print]
  Fast analysis of caffeinated beverages using laser diode thermal desorption mass spectrometry (LDTD-MS/MS).
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Tobacco

• Int J Environ Res Public Health 2019 Sep 4;16(18):3234
  Estimating the potential public health impact of prohibiting characterizing flavors in cigars throughout the US.
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Toxicological Research

• Microorganisms 2019 Sep 6;7(9):325
  Effects of acute and chronic exposure to residual level erythromycin on human intestinal epithelium cell permeability and cytotoxicity.
• Mol Neurobiol 2019 Sep 5 [Epub ahead of print]
  Downregulation of 14-3-3 proteins in Alzheimer's disease.
• Methods Mol Biol 2019;2031:59-75
  Detection of in vivo mutation in the Hprt and Pig-a genes of rat lymphocytes.
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