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*
