JSM 2011 Online Program

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131	Mon, 8/1/2011, 8:30 AM - 10:20 AM	CC-B114
Topics with Noninferiority and Equivalence Trials — Contributed Papers
Biopharmaceutical Section
Chair(s): Farid Kianifarid, Novartis
8:35 AM	Noninferiority Margin for Longitudinal Data: The Timolol Ophthalmic Solution Example — Rima Izem, U.S. Food and Drug Administration/CDER
8:50 AM	A More Powerful Test Based on Ratio Distribution for Retention Noninferiority Hypothesis — Ling Deng, Johnson & Johnson Pharmaceutical R&D, LLC ; Gang Chen, Johnson & Johnson Pharmaceutical R&D, LLC
9:05 AM	Justification of Noninferiority Design in Infection Disease Studies — Chunzhang Wu, Astellas Pharma Global Development, Inc.
9:20 AM	Statistical Considerations in Assessing Assay Sensitivity in a Noninferiority Trial — Isaac Nuamah, Johnson & Johnson Pharmaceutical R&D, LLC
9:35 AM	Unifying Frequentist and Bayesian Approaches in Noninferiority Testing — Mark A. Gamalo, U.S. Food and Drug Administration/CDER/OTS/OB ; Ram C. Tiwari, U.S. Food and Drug Administration/CDER/OTS/OB
9:50 AM	Floor Discussion

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