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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