Legend:
CC = Vancouver Convention Centre F = Fairmont Waterfront Vancouver
* = applied session ! = JSM meeting theme
Activity Details
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631 !
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Thu, 8/2/2018,
8:30 AM -
10:20 AM
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CC-West 114
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Clinical Trial Design- 7 — Contributed Papers
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Biopharmaceutical Section
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Chair(s): Yuqi Chen, Amgen
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8:35 AM
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Impact of Clinical Center Effects on Objective Response Rate
Fang Liu, Merck & Co., Inc; Cong Chen, Merck & Co.
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8:50 AM
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Utility and Challenges of Applying Quantitative Benefit-Risk Assessment for Regulatory Decision Making
Weili He, AbbVie; Bo Fu, Astellas Pharma Inc.; John Scott, FDA
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9:05 AM
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Does it Pay to Repeat the Baseline?
Shiyang Ma, University of Rochester; David Oakes , University of Rochester
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9:20 AM
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Extension to Signature Design
Xiting Yang, Food and Drug Administration
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9:35 AM
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A Unified Framework for Weighted Parametric Multiple Test Procedures
Dong Xi, Novartis Pharmaceuticals; Ekkehard Glimm, Novartis; Willi Maurer, Novartis; Frank Bretz, Novartis Pharma AG
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9:50 AM
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Target Toxicity Design for Phase 1 Dose-Finding: a Safe and Reliable Method
Bob Zhong, Johnson and Johnson; Wenchuan Guo, University of California Riverside
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10:05 AM
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Bayesian Extrapolation in Pediatric Clinical Trials
Mehreteab F Aregay, Novartis; David Ohlssen, Novartis; Heinz Schmidli, Novartis Pharamceutical Corporation
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