JSM 2012 Online Program
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Online Program HomeActivity Details
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167 * | Mon, 7/30/2012, 10:30 AM - 12:20 PM | CC-Room 21 | |
Drug Safety: Regulatory and Statistical Considerations — Topic Contributed Papers | |||
Biopharmaceutical Section | |||
Organizer(s): Xiao Ding, Gilead Sciences | |||
Chair(s): Yi Tsong, FDA/CDER | |||
10:35 AM | Propensity Score Methodology Application to Drug and Device Safety Studies: Regulatory Perspectives — Lilly Yue, FDA ; Mark S Levenson, FDA | ||
10:55 AM | Time-to-Event Meta-Analysis for Rare Safety Outcomes — Xiao Ding, Gilead Sciences ; Mat Soukup, FDA/CDER ; Bradley McEvoy, FDA/CDER | ||
11:15 AM | Responder Analysis in Human Abuse Potential Studies — Ling Chen, FDA | ||
11:35 AM | Concentration-QTc Modeling Approach — Joanne Zhang, FDA/CDER | ||
11:55 AM | Discussant: Jie Chen, Merck Serono (Beijing) R&D Hub | ||
12:15 PM | Floor Discussion |
2012 JSM Online Program Home
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