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* = applied session ! = JSM meeting theme
Activity Details
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374 * !
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Thu, 8/12/2021,
12:00 PM -
1:50 PM
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Virtual
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Statistical Approaches for Evidence Integration and Considerations to Communication in Product Labeling — Topic-Contributed Papers
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Biopharmaceutical Section, Health Policy Statistics Section, Biometrics Section
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Organizer(s): Jennifer Clark, FDA
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Chair(s): Ross Bray, Eli Lilly and Company
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12:05 PM
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Unified Framework of Meta-Analysis, Composite Likelihoods, and Bayesian Methods for Evidence Integration in Pediatric Extrapolation Development Archetypes
Margaret Gamalo-Siebers, Pfizer Inc.; Junjing Lin, Takeda Pharmaceuticals
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12:25 PM
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Using Robust Bayesian Priors to Borrow Information from Historical Adult Trials for a Clinical Trial in Pediatric Multiple Sclerosis
Marius Thomas, Novartis; David Ohlssen, Novartis; Heinz Schmidli, Novartis; Dieter Haering, Novartis
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12:45 PM
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Extrapolating Adult Efficacy Data to Pediatric Populations via Bayesian Hierarchical Models
Benjamin R Saville, Berry Consultants; Kert Viele, Berry Consultants
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1:05 PM
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Partial Extrapolating of Efficacy from Adult to Pediatrics: A Case Study in Systemic Lupus Erythematosus
Juan Jose Abellan, GSK
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1:25 PM
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Discussant: James Travis, FDA
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1:45 PM
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Floor Discussion
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