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