This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Activity Details

394 * Tue, 8/3/2010, 2:00 PM - 3:50 PM CC-220 (West)
Statistical Issues in Multiregional and Bridging Trials — Topic Contributed Papers
Biopharmaceutical Section , ENAR
Organizer(s): Yi Tsong, CDER/FDA
Chair(s): Ling Chen, FDA
2:05 PM Strategies for Global Drug Development: Bridging vs. Multiregional Clinical Trials — William Wang, Merck & Co., Inc. ; William Malbecq, Merck & Co., Inc.
2:25 PM Evaluation of the Strength of Bridging Evidence — Hsiao-Hui Tsou, National Health Research Institutes, Taiwan ; Jung-Tzu Liu, National Health Research Institutes, Taiwan ; Chin-Fu Hsiao, National Health Research Institutes, Taiwan ; Yi Tsong, CDER/FDA
2:45 PM Exploration of Regional Impact on Efficacy Data in Antidepressant Clinical Trials — Peiling Yang, FDA
3:05 PM Regulatory and Statistical Issues in Multiregional Trials: Case Studies — Daphne T.Y. Lin, FDA ; Greg Soon, CDER/FDA ; Wen Zeng, FDA
3:25 PM Evaluation of Regional Treatment Effect in a Multiregional Clinical Trial — Yi Tsong, CDER/FDA ; W-J Chang, National Health Research Institutes, Taiwan ; Chin-Fu Hsiao, National Health Research Institutes, Taiwan ; Hsiao-Hui Tsou, National Health Research Institutes, Taiwan
3:45 PM Floor Discussion



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