JSM 2011 Online Program
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Activity Details
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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 |
2011 JSM Online Program Home
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