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Abstract:
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Much emphasis has been placed on the structured benefit:risk assessment globally. Pharmaceutical companies are increasingly using structured benefit-risk assessments. FDA has already begun to develop such approaches, both for drugs/biologics and for medical devices. The Quantitative Sciences in the Pharmaceutical Industry (QSPI) Benefit-Risk Working Group (BRWG) has been actively pursuing several emerging topics in BR assessment. This presentation will provide an overview of structured benefit:risk analysis, discuss emerging work in benefit-risk assessment from the Quantitative Sciences in the Pharmaceutical Industry (QSPI) Benefit-Risk Working Group (BRWG), and provide some recommendations on benefit-risk evaluations from an industry perspective.
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