Scientific Publications by FDA Staff

Recent Scientific Publications: Biologics

• Pharm Stat 2013 Apr 29 [Epub ahead of print]
  Bayesian design and analysis of composite endpoints in clinical trials with multiple dependent binary outcomes.
• Viruses 2013, May; 1-x manuscripts
  Influence of naturally-occurring simian foamy viruses (SFV) on SIV disease progression in the rhesus macaque (Macaca mulatta) model
• BMC Genomics 2013 Feb 20;14:116
  Globin gene expression in correlation with G protein-related genes during erythroid differentiation.
• FEBS J 2013 Mar;280(6):1542-62
  Proteome-wide analysis of nonsynonymous single-nucleotide variations in active sites of human proteins.
• Vaccine 2013 Apr 11 [Epub ahead of print]
  Pharmacokinetic modeling as an approach to assessing the safety of residual formaldehyde in infant vaccines.
• J Proteome Res 2013 Mar 1;12(3):1289-99
  A Coordinated Proteomic Approach for Identifying Proteins that Interact with the E. coli Ribosomal Protein S12.
• AJR Am J Roentgenol 2013 Mar;200(3):529-36
  Comparison of coronary CT angiography image quality with and without breast shields.
• J Virol 2013 Mar;87(6):3277-83
  In Vivo Selection of H1N2 Influenza Virus Reassortants in the Ferret Model.
• J Biomed Mater Res A 2013 Mar 27 [Epub ahead of print]
  Different molecular weight hyaluronic acid effects on human macrophage interleukin 1beta production.
• Eur J Immunol 2013 Feb;43(2):427-38
  Tracking antigen-specific CD4(+) T cells throughout the course of chronic Leishmania major infection in resistant mice.
• J Virol 2013 Mar 13 [Epub ahead of print]
  Herpes Simplex Virus 2 expresses a novel form of ICP34.5, a major viral neurovirulence factor, through regulated alternative splicing.
• Vaccine 2013 Mar 6 [Epub ahead of print]
  Enhanced expression of HIV and SIV vaccine antigens in the structural gene region of live attenuated rubella viral vectors and their incorporation into virions.
• Leuk Lymphoma 2013 Mar;54(3):579-86
  Quantitative detection of zeta-chain-associated protein 70 expression in chronic lymphocytic leukemia.
• Annu Rev Biophys 2013 Feb 28 [Epub ahead of print]
  Structural Insights into the Evolution of the Adaptive Immune System.
• J Bacteriol 2013 Apr 12 [Epub ahead of print]
  Analysis of novel iron-regulated, surface anchored, hemin-binding proteins in Corynebacterium diphtheriae.
• J Leukoc Biol 2013 Feb 25 [Epub ahead of print]
  IL-12Rbeta2 is critical for survival of primary Francisella tularensis LVS infection.
• Virol J 2012 Oct 26;9:246
  Whole genome sequencing of phage resistant Bacillus anthracis mutants reveals an essential role for cell surface anchoring protein CsaB in phage AP50c adsorption.
• PLoS One 2013;8(2):e56081
  A Peptide Derived from Phage Display Library Exhibits Antibacterial Activity against E. coli and Pseudomonas aeruginosa.
• EMBO J 2013 Mar 6;32(5):756-69
  Post-translational changes to PrP alter transmissible spongiform encephalopathy strain properties.
• J Autoimmun 2012 Dec;39(4):294-303
  Porphyromonas gingivalis promotes Th17 inducing pathways in chronic periodontitis.
• JAMA 2013 Jan 16;309(3):236-7
  Expedited review of new drugs.
• Xenobiotica 2013 Feb 7 [Epub ahead of print]
  Allometric scaling and prediction of concentration-time profiles of coagulation factors in humans from animals.
• N Engl J Med 2013 Feb 21;368(8):689-91
  Yellow Fever Outbreak in Sudan.
• PLoS One 2013 Apr 23;8(4):e62576
  Anthrax lethal toxin downregulates claudin-5 expression in human endothelial tight junctions.
• Pharmacogenomics 2013 Apr;14(5):459-63
  Combining genetic variations in CYP2C9 and VKORC1 with clinical factors for warfarin dosing determination improved clinical effectiveness.