Legend:
CC = Vancouver Convention Centre F = Fairmont Waterfront Vancouver
* = applied session ! = JSM meeting theme
Activity Details
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524
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Wed, 8/1/2018,
10:30 AM -
12:20 PM
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CC-West 111
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Statistical Issues in Drug Development - 2 — Contributed Papers
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Biopharmaceutical Section
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Chair(s): Hui Yang, Amgen Inc.
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10:35 AM
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Application of the Win Ratio for Benefit-Risk Analysis
T. Ceesay, Merck ; Shahrul Mt-Isa, Merck; Joseph F. Heyse, Merck Research Laboratories
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10:50 AM
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A Simulation Study of Consistency Evaluation Between Local and Global Results in Multi-Regional Clinical Trials
Chunsheng He, Bristol-Myers Squibb; Jingyi Lin, Duke University; Stephane Munier, Bristol-Myers Squibb; Shein-Chung Chow, Duke University; Lisa Ying
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11:05 AM
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A Comparison of Statistical Models for Recurrent Events with Applications to Hospitalization and Death Events
Jihong Chen, Alnylam Pharmaceuticals; Tim Lin, Alnylam Pharmaceuticals; Matthew T. White, Alnylam Pharmaceuticals; Christine Powell, Alnylam Pharmaceuticals; Andrew Strahs, Alnylam Pharmaceuticals
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11:20 AM
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Addressing the Issue of Subject Confusion Due to the Use of Two Visual Analog Scales in Human Abuse Potential Studies
Ling Chen, CDER, FDA
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11:35 AM
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Rescue Medications from a Statistical Perspective - Case Studies and More
qing li, merck; Man (Mandy) Jin, Merck & Co., Inc.
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11:50 AM
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Propensity Score Methods for Efficacy Comparison in the Lack of Randomization
Qing Li, University of Iowa; Guang Chen, Celgene Corp.
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12:05 PM
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An Evaluation of Statistical Approaches to Post Marketing Surveillance
Yuxin Ding, University at Buffalo; Marianthi Markatou, University at Buffalo; Robert Ball, U.S. Food and Drug Administration,Center for Drug Evaluation and Research
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