Affiliation:
1. Sanofi, Bridgewater, 55 Corporate Drive, Bridgewater, NJ 08807, USA
Abstract
In the last two decades there has been a shift in the approach to evaluating the benefit–risk (BR) profiles of medicinal products from an unstructured, subjective, and inconsistent, to a more structured and objective, process. This article describes that shift from a historical perspective; the past, the present, and the future, and highlights key events that played critical roles in changing the field.
Reference43 articles.
1. Benefit-risk Assessment of Investigational Drugs: Current Methodology, Limitations, and Alternative Approaches
2. Rawlins M. Trading risk for benefit. Risk and consent to risk in medicine. London: Parthenon Publishing, 1989, pp.193–202.
3. Concepts in Risk-Benefit Assessment A Simple Merit Analysis of a Medicine?
4. CIOMS. Benefit-risk balance for marketed drugs: evaluating safety signals. Geneva: CIOMS Working Group IV, Council for International Organizations of Medical Sciences (CIOMS), 1998, pp. 21–22.
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