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Legend: Palais des congrès de Montréal = CC, Le Westin Montréal = W, Intercontinental Montréal = I
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Activity Details

32 * Sun, 8/4/2013, 2:00 PM - 3:50 PM CC-512h
Analysis of Safety Data and Rare Events — Contributed Papers
Biopharmaceutical Section , Korean International Statistical Society
Chair(s): Mary Bartholomew, FDA Center for Veterinary Medicine
2:05 PM Statistical Methods Used in Safety Evaluation for NDA Submissions Linyun Zhou, Takeda Global Research & Development
2:20 PM A Single-Arm Sequental Monitoring Design for Claiming Positive or Negative Safety Signals in Patients from Multiple Baseline Risk Groups Jung Wook Park, Astellas Pharma Global Development, Inc. ; Xiaosha Sherman Zhang, Astellas Pharma Global Development, Inc. ; Jay Yang, Astellas Pharma Global Development Inc. ; Stephen Eck, Astellas Pharma Global Development, Inc.
2:35 PM A Second Source of Conservatism in Fisher's Exact Test for Rare Events Mark Von Tress, Alcon Laboratories
2:50 PM Performance of Various Propensity Score Estimation Techniques for Estimating Relative Risks: A Simulation Study Jiaxiao Shi, Kaiser Permanente ; Wansu Chen, Kaiser Permanente
3:05 PM Large-Scale Penalized Regression for Propensity Score Estimation in Observational Health Care Data Ivan Zorych, Columbia University ; Patrick Ryan, Jenssen Research and Development LLC ; David Madigan, Columbia University
3:20 PM Signal Detections in Drug Safety Research Li Zhu, Amgen ; Padmaja Chiruvolu, Amgen Inc ; Maggie Chen, Assent Consulting ; Liying Zhang, Assent Consulting ; Jinyu Yuan, Kforce ; Qi Jiang, Amgen
3:35 PM A Further Look Into Meta-Analysis of Rare Event Data for Drug Safety Assessment Yujun Wu, Sanofi US ; Hui Quan, Sanofi ; Peng-liang Zhao, Sanofi US

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