Benefit-risk Assessment of Investigational Drugs: Current Methodology, Limitations, and Alternative Approaches
Author:
Publisher
Wiley
Subject
Pharmacology (medical)
Reference215 articles.
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2. Regulatory Decision‐Making in the United States Based on a Single Pivotal Clinical Study: Principles and Precedents;Clinical Research and Regulatory Affairs;2004-01
3. Benefit-risk analysis: a proposal using quantitative methods;Pharmacoepidemiology and Drug Safety;2003
4. Pharmacovigilence;Encyclopedia of Clinical Pharmacy;2002-11
5. Risk/Benefit Assessment of New Drugs: Perspectives of a Former FDA Advisory Committee Member;Drug Information Journal;1993-10
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