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Importance and challenges of studying marketed drugs: what is a phase IV study? Common clinical research designs, registries, and self-reporting systems
- Source :
- Journal of Clinical Pharmacology. September 2007, Vol. 47 Issue 9, p1074, 13 p.
- Publication Year :
- 2007
-
Abstract
- The new drug application database submitted to the US Food and Drug Administration for drug approval (phases I-III or phases 1-3) is limited both in scope and size. Although randomized [...]
- Subjects :
- United States. Food and Drug Administration -- Laws, regulations and rules
Prevention
Laws, regulations and rules
Government regulation
Clinical trials -- Laws, regulations and rules
Adverse drug reactions -- Prevention
Drug approval -- Laws, regulations and rules
Drugs -- Adverse and side effects
Subjects
Details
- Language :
- English
- ISSN :
- 00912700
- Volume :
- 47
- Issue :
- 9
- Database :
- Gale General OneFile
- Journal :
- Journal of Clinical Pharmacology
- Publication Type :
- Academic Journal
- Accession number :
- edsgcl.193812849