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JSM 2012 Online Program

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Activity Details

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

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