Pharmacometrics at FDA: Evolution and Impact on Decisions
| Autor: | Jogarao V. S. Gobburu, J R Powell |
|---|---|
| Rok vydání: | 2007 |
| Předmět: |
Drug
Research design Biometry Process management Operations research media_common.quotation_subject Decision Making MEDLINE History 21st Century Models Biological Product Surveillance Postmarketing Humans Medicine Computer Simulation Pharmacokinetics Pharmacology (medical) Quality (business) Product (category theory) Drug Approval Drug Labeling media_common Pharmacology Clinical Trials as Topic Dose-Response Relationship Drug United States Food and Drug Administration business.industry Health Policy History 20th Century United States Pharmacometrics Clinical trial Drug development Research Design Pharmacology Clinical Government Regulation business |
| Zdroj: | Clinical Pharmacology & Therapeutics. 82:97-102 |
| ISSN: | 1532-6535 0009-9236 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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