JSM 2011 Online Program

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Activity Details

501 Wed, 8/3/2011, 10:30 AM - 12:20 PM CC-D241
Statistical Considerations in Bioequivalence, Therapeutic Equivalence, Biosimilarity, and Noninferiority Investigations — Topic Contributed Papers
Biopharmaceutical Section , ENAR
Organizer(s): Kallappa M. Koti, U.S. Food and Drug Administration
Chair(s): Mark A. Gamalo, U.S. Food and Drug Administration/CDER/OTS/OB
10:35 AM Evaluating Bioequivalence of Two AUCs Obtained from Sparse or Incomplete Sampling in Parallel Designs Steven Hua, Pfizer Inc. ; Jihao Zhou, Pfizer Inc.
10:55 AM Stratified Analysis of Bioequivalence and Therapeutic Equivalence Trials Data When the Metric Is Ratio of Parameters Kallappa M. Koti, U.S. Food and Drug Administration
11:15 AM On Analysis of the Difference of Two Exposure-Adjusted Poisson Rates Ivan S. F. Chan, Merck Research Laboratories ; William W. B. Wang, Merck Research Laboratories
11:35 AM Assessing Noninferiority in Multiregion Trial Using the Bayesian Approach Satrajit Roychoudhury, Novartis
11:55 AM Discussant: Debajyoti Sinha, Florida State University
12:15 PM Floor Discussion

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