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680 * ! | Thu, 8/13/2015, 10:30 AM - 12:20 PM | CC-611 | |
Benefit-Risk Assessment to Support Decision-Making in Drug Development and Regulatory Assessment — Topic Contributed Papers | |||
Biopharmaceutical Section , Committee on Applied Statisticians | |||
Organizer(s): Bo Fu, AbbVie | |||
Chair(s): Bo Fu, AbbVie | |||
10:35 AM | Two Statistical Approaches to Incorporate Data Uncertainty into Multiple Criteria Decision Analysis (MCDA) for Benefit-Risk Assessment of Medical Products — Shihua Wen, AbbVie | ||
10:55 AM | The Influence of Clinically and Statistically Meaningful Differences in Risk Benefit: A Case Study of the First Approved Allergenic Sublingual Immunotherapy (SLIT) Products — Tammy Massie | ||
11:15 AM | Developing a Benefit-Risk Process That Becomes Fully Integrated into Developmental Processes and Decision-Making Within a Biopharmaceutical Organization — Mondira Bhattacharya, AbbVie ; Rebecca B. Reindel, AbbVie | ||
11:35 AM | Benefit-Risk Assessment in the Absence of Established Definition of Responders — Amarjot Kaur, Merck Research Laboratories ; Ziliang Li, Merck Research Laboratories | ||
11:55 AM | Discussant: Jerald Schindler, Merck Research Laboratories | ||
12:15 PM | Floor Discussion |
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