Legend:
CC = Colorado Convention Center H = Hyatt Regency Denver at Colorado Convention Center
* = applied session ! = JSM meeting theme
Activity Details
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507
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Wed, 7/31/2019,
10:30 AM -
12:20 PM
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CC-210/212
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Non-Inferiority, Biosimilarity and Related Topics — Contributed Papers
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Biopharmaceutical Section
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Chair(s): Junjing Lin, AbbVie
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10:35 AM
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Use of Tolerance Intervals for Assessing Biosimilarity
Chian Chen, Institute of Population Health Sciences, National Health Research Institutes; Chin-Fu Hsiao, National Health Research Institutes
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10:50 AM
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Incomplete Data Analysis of Non-Inferiority Clinical Trials: Difference in Binomial Proportions Case
Yulia Sidi, University of Connecticut; Ofer Harel, Dept of Statistics, U of Connecticut
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11:05 AM
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Theory and Practice of Equivalence and Non-Inferority Analyzes
Kallappa M. Koti, FDA (Retired)
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11:20 AM
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Assessing the Ratio of Means as a Causal Estimand in Clinical Endpoint Bioequivalence Studies in the Presence of Intercurrent Events
Yiyue Lou, University of Iowa College of Public Health; Michael P. Jones, University of Iowa College of Public Health; Wanjie Sun, FDA
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11:35 AM
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New Approaches for Testing Non-Inferiority for Three-Arm Trials with Poisson Distributed Outcomes
Erina Paul, Merck & Co Inc.; Samiran Ghosh, Wayne State University; Shrabanti Chowdhury, Icahn School of Medicine at Mount Sinai
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11:50 AM
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Statistician’s Perspective of Meta-Analysis to Establish Non-Inferiority Margin for Phase 3 Study
Aparna Raychaudhuri, CSL Behring; Fanny Mitrani-Gold, GlaxoSmithKline
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12:05 PM
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A Framework for Considering the Risk-Benefit Trade-Off in Designing Trials Using Non-Inferiority or Composite Outcome Approaches
Ritesh Ramchandani, Harvard University; Grace Montepiedra, Harvard University; Soyeon Kim, Harvard University; Sachiko Miyahara, Harvard University
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