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Activity Details

326 Tue, 8/6/2013, 10:30 AM - 12:20 PM CC-513b
Critical Aspects of Dose-Finding in Drug Development — Invited Papers
Biopharmaceutical Section , Biometrics Section
Organizer(s): David I. Ohlssen, Novartis Pharmaceuticals Corporation
Chair(s): David I. Ohlssen, Novartis Pharmaceuticals Corporation
10:35 AM Contribution of Different Design Components to the Efficiency of Response-Adaptive Dose-Ranging Studies Vladimir Dragalin, Aptiv Solutions
11:00 AM Leveraging Longitudinal Data in Dose-Finding Studies Chyi-Hung Hsu, Janssen Research & Development ; Jose Carlos Pinheiro, Janssen R&D
11:25 AM Sizing a Phase IIb Trial: Using the Predictive Values from a Nonlinear Model Jerry John Weaver, Novartis Pharmaceuticals Corporation
11:50 AM Discussant: Yanming Yin, FDA
12:10 PM Floor Discussion

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