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JSM 2012 Online Program

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Activity Details

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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