JSM 2012 Online Program
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Online Program HomeActivity Details
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650 * | Thu, 8/2/2012, 10:30 AM - 12:20 PM | CC-Room 23C | |
Statistical Considerations in Design and Analysis of Bridging and Multi-Regional Trials — Topic Contributed Papers | |||
Biopharmaceutical Section | |||
Organizer(s): Yi Tsong, FDA/CDER | |||
Chair(s): Xiao Ding, Gilead Sciences | |||
10:35 AM | Weighted Z-Test and Weighted Evidence Approaches of Testing Bridging Evidence Into a New Region — Xiaoyu Dong, MedImmune ; Yu Guo, University of Maryland ; Yi Tsong, FDA/CDER | ||
10:55 AM | Decision Rules and Associated Sample Size Planning for Regional Approval Utilizing Multiregional Clinical Trials — Nelson Lu, FDA ; Rajesh Nair, FDA ; Yunling Xu, FDA | ||
11:15 AM | Design and Evaluation of Multiregional Clinical Trials: Experience in Japan — Yuki Ando, Pharmaceuticals & Medical Devices Agency | ||
11:35 AM | A Predictive Bayesian Approach to the Design and Analysis of Bridging Studies — A. Lawrence Gould, Merck ; Tian Jin, Shanghai University of Finance and Economics ; Li Xin Zhang, MSD (Shanghai) Pharma Co. ; William W. B. Wang, MSD (Shanghai) Pharma Co. | ||
11:55 AM | Discussant: Yi Tsong, FDA/CDER | ||
12:15 PM | Floor Discussion |
2012 JSM Online Program Home
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