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CC = Colorado Convention Center   H = Hyatt Regency Denver at Colorado Convention Center
* = applied session       ! = JSM meeting theme

Activity Details

507 Wed, 7/31/2019, 10:30 AM - 12:20 PM CC-210/212
Non-Inferiority, Biosimilarity and Related Topics — Contributed Papers
Biopharmaceutical Section
Chair(s): Junjing Lin, AbbVie
10:35 AM 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
10:50 AM 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
11:05 AM Theory and Practice of Equivalence and Non-Inferority Analyzes

Kallappa M. Koti, FDA (Retired)
11:20 AM 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
11:35 AM 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
11:50 AM Statistician’s Perspective of Meta-Analysis to Establish Non-Inferiority Margin for Phase 3 Study

Aparna Raychaudhuri, CSL Behring; Fanny Mitrani-Gold, GlaxoSmithKline
12:05 PM 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