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Activity Number: 492
Type: Topic Contributed
Date/Time: Wednesday, August 6, 2014 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #313025 View Presentation
Title: Weight in Benefit-Risk Evaluation
Author(s): Yabing Mai*+ and Weili He
Companies: Merck and Merck
Keywords: Weight ; Benefit-Risk Evaluation ; Weighted Analysis
Abstract:

The assignment and assessment of weight is an important component of benefit-risk (BR) evaluation. An appropriately weighted analysis can provide enhanced qualitative and/or quantitative evidence to the experimental entity's BR profile. In this presentation we review some mostly used weighting schemes in BR evaluation available from published literature and regulatory document. The discussion is focused on the currently existing methodology's accessibility, feasibility and practicability along with the targeted areas of usage in clinical development space. In addition, we propose a framework to specifically assess the readiness and completeness of the conditions required for an ideal weighted analysis.


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