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Pharmacometrics at FDA: Evolution and Impact on Decisions
Author(s) -
Powell J R,
Gobburu J V S
Publication year - 2007
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/sj.clpt.6100234
Subject(s) - food and drug administration , clinical trial , clinical pharmacology , drug development , product (mathematics) , drug , new drug application , new product development , pharmacology , quality (philosophy) , medicine , business , risk analysis (engineering) , marketing , philosophy , geometry , mathematics , epistemology , pathology
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. Clinical Pharmacology & Therapeutics (2007) 82 , 97–102. doi: 10.1038/sj.clpt.6100234 ; published online 30 May 2007