Scientific Publications by FDA Staff

Recent Scientific Publications: Drugs

• J Mol Struct 2012 Aug 8;1020:112-20
  THz spectroscopy: An emerging technology for pharmaceutical development and pharmaceutical Process Analytical Technology (PAT) applications
• Biom J 2013 May;55(3):271-4
  MCP2011-The 7th international conference on multiple comparison procedures.
• Int J Pharm 2013 Apr 22 [Epub ahead of print]
  Impact of controlled ice nucleation on process performance and quality attributes of a lyophilized monoclonal antibody.
• Biom J 2013 May;55(3):420-9
  Multiple comparisons in complex clinical trial designs.
• Drug Saf 2013 Apr 26 [Epub ahead of print]
  Baseline Correction in Parallel Thorough QT Studies.
• N Engl J Med 2013 Apr 24 [Epub ahead of print]
  New Evidence about an Old Drug - Risk with Codeine after Adenotonsillectomy.
• J Immunol 2013 Apr 24 [Epub ahead of print]
  Human Fc Receptor-Like 5 Binds Intact IgG via Mechanisms Distinct from Those of Fc Receptors.
• Clin Exp Immunol 2013 Feb 26 [Epub ahead of print]
  Matrix Metalloproteinases Inhibition Promotes the Polyfunctionality of Human Natural Killer Cells in Therapeutic Antibody-based Anti-tumor Immunotherapy.
• JAMA Pediatr 2013 Mar 1;167(3):243-9
  Migraine therapeutics in adolescents: a systematic analysis and historic perspectives of triptan trials in adolescents.
• J Biol Chem 2013 Apr 18 [Epub ahead of print]
  HSP90 functions to stabilize and activate the testis-specific serine/threonine kinases, a family of kinases essential for male fertility.
• Clin Pharmacol Ther 2013 Apr 3 [Epub ahead of print]
  Regulatory and Scientific Issues Regarding Use of Foreign Data in Support of New Drug Applications in the U.S.: An FDA Perspective.
• Pediatr Infect Dis J 2013 Apr 11 [Epub ahead of print]
  Potential for Palivizumab Interference with Commercially Available Antibody-Antigen Based Respiratory Syncytial Virus Diagnostic Assays.
• BMC Genomics 2013 Mar 5;14:147
  Comparison of the global gene expression of choroid plexus and meninges and associated vasculature under control conditions and after pronounced hyperthermia or amphetamine toxicity.
• Stat Med 2013 Mar 30;32(7):1079-111
  Key multiplicity issues in clinical drug development.
• Hepatology 2013 Feb;57(2):856
  Clinical Relevance of Detectable Hepatitis C Virus RNA in the Context of Direct-Acting Antivirals - Reply
• Pharmacoepidemiol Drug Saf 2013 Mar;22(3):324-8
  Safe lists for medications in pregnancy: inadequate evidence base and inconsistent guidance from Web-based information, 2011.
• J Natl Cancer Inst 2013 Apr 11 [Epub ahead of print]
  Comparative Effectiveness Research in Cancer: What Has Been Funded and What Knowledge Gaps Remain?
• Analyst 2013 Apr 12 [Epub ahead of print]
  Structural comparison of two anti-CD20 monoclonal antibody drug products using middle-down mass spectrometry.
• Oncologist 2013 Apr 10 [Epub ahead of print]
  Approval Summary: Cetuximab in Combination With Cisplatin or Carboplatin and 5-Fluorouracil for the First-Line Treatment of Patients With Recurrent Locoregional or Metastatic Squamous Cell Head and Neck Cancer.
• J Thromb Haemost 2013 Apr 11 [Epub ahead of print]
  Drospirenone and non-fatal venous thromboembolism: Is there a risk difference by dosage of Ethinyl-Estradiol?
• AAPS J 2013 Apr 10 [Epub ahead of print]
  Generic Development of Topical Dermatologic Products, Part II: Quality by Design for Topical Semisolid Products.
• Clin Pharmacol Ther 2013 Feb 12 [Epub ahead of print]
  Clinical Pharmacology and the Catalysis of Regulatory Science: Opportunities for the Advancement of Drug Development and Evaluation.
• J Innate Immun 2013 Apr 6 [Epub ahead of print]
  CD300c is an Activating Receptor Expressed on Human Monocytes.
• Am J Transplant 2013 Apr 8 [Epub ahead of print]
  Summary of FDA Workshop on Ischemia Reperfusion Injury in Kidney Transplantation.
• J Clin Oncol 2013 Apr 8 [Epub ahead of print]
  Modified Toxicity Probability Interval Design: A Safer and More Reliable Method Than the 3 + 3 Design for Practical Phase I Trials.