Healthy Skepticism Library item: 11292

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Powell JR, Gobburu JV.
Pharmacometrics at FDA: evolution and impact on decisions.
Clin Pharmacol Ther 2007 Jul; 82:(1):97-102
http://www.nature.com/clpt/journal/v82/n1/abs/6100234a.html;jsessionid=CB5CB77AC8F93A324BAD850866E7144B

Abstract:

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.

Keywords:
Publication Types: Historical Article Review MeSH Terms: Biometry*/history Clinical Trials/history Clinical Trials/legislation & jurisprudence Clinical Trials/methods Clinical Trials/trends* Computer Simulation Decision Making* Dose-Response Relationship, Drug Drug Approval*/history Drug Labeling Government Regulation*/history Health Policy/history Health Policy/trends* History, 20th Century History, 21st Century Humans Models, Biological Pharmacokinetics Pharmacology, Clinical/history Pharmacology, Clinical/legislation & jurisprudence Pharmacology, Clinical/methods Pharmacology, Clinical/trends* Product Surveillance, Postmarketing Research Design United States United States Food and Drug Administration/history United States Food and Drug Administration/trends*