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- Title
The Pivotal Role of Postapproval Research.
- Authors
Gliklich, Richard E.
- Abstract
Focuses on the importance of the Critical Path Initiative on the development and approval of safety and effectiveness of pharmaceutical and medical devices according to the U.S. Food and Drug Administration. Implementation of the postapproval research programs; Identification of robust surrogate endpoints; Use of predictive tools for performance after actual product launch.
- Subjects
UNITED States; PHARMACEUTICAL research; DRUG efficacy; MEDICAL equipment; UNITED States. Food &; Drug Administration
- Publication
Applied Clinical Trials, 2005, Vol 14, Issue 8, p52
- ISSN
1064-8542
- Publication type
Article