Pharmacometrics at FDA: evolution and impact on decisions.
Drug development and regulatory decisions are driven by information that is compiled primarily from clinical trials and other supportive experiments, but also through clinical experience in the post-market period. The wisdom of these decisions determines the efficiency of drug development, the decision to approve the drug, and the resultant drug product quality including guidance on how to use the product known as the label. Although the decisions are usually simple in nature (e.g., trial design and project progression at the company, product and labeling approval at the Food and Drug Administration (FDA)), the information informing the decision is complex and diverse.
Powell
J R
JR
Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland, USA. robert.powell@fda.hhs.gov
Gobburu
J V S
JV
D001699:Biometry / Q000266:history; D002986:Clinical Trials as Topic / Q000266:history / Q000331:legislation & jurisprudence / Q000379:methods / Q000639:trends*; D003198:Computer Simulation; D003657:Decision Making; D004305:Dose-Response Relationship, Drug; D017277:Drug Approval / Q000266:history; D004348:Drug Labeling; D033161:Government Regulation / Q000266:history; D006291:Health Policy / Q000266:history / Q000639:trends*; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D008954:Models, Biological; D010599:Pharmacokinetics; D010601:Pharmacology, Clinical / Q000266:history / Q000331:legislation & jurisprudence / Q000379:methods / Q000639:trends*; D011358:Product Surveillance, Postmarketing; D012107:Research Design; D014481:United States; D014486:United States Food and Drug Administration / Q000266:history / Q000639:trends*