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160 * ! | Mon, 8/10/2015, 10:30 AM - 12:20 PM | CC-3B | |
Statistical Methods in Drug Safety from Clinical Trial to Post-Market — Invited Papers | |||
Biopharmaceutical Section , Government Statistics Section , Biometrics Section | |||
Organizer(s): Shihua Wen, AbbVie | |||
Chair(s): Jingyi Liu, Eli Lilly and Company | |||
10:35 AM | On Incremental Incidence Rates in Long-Term Cohort Safety Studies — Girish Aras, Amgen | ||
10:55 AM | Application of a Historical Control Database to Characterize Adverse Events in a Vaccine-Eligible Population — Prakash Bhuyan, Pfizer Inc. | ||
11:15 AM | Comparison of Bayesian and Frequentist Meta-Analytical Approaches for Analyzing Time-to-Event Data — Brenda Crowe, Eli Lilly and Company | ||
11:35 AM | Advancing Safety Analyzes in Drug Development: Innovative Statistical Approaches and Real-World Examples---Phase 1 Through Post-Marketing — Andrea Best, AbbVie | ||
11:55 AM | Discussant: Aloka Chakravarty, FDA/CDER | ||
12:15 PM | Floor Discussion |
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