Pharmacogenomics in Drug Development and Regulatory Decision-making: the Genomic Data Submission (GDS) Proposal.
Salerno
Ronald A
RA
Worldwide Regulatory Affairs, Wyeth Research, Collegeville, PA 19426, USA. Salernr@wyeth.com
Lesko
Lawrence J
LJ
D000818:Animals; D002986:Clinical Trials as Topic / Q000592:standards; D003657:Decision Making; D015195:Drug Design; D023281:Genomics / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards; D033161:Government Regulation; D006801:Humans; D010597:Pharmacogenetics / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards; D011050:Policy Making; D012107:Research Design / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration