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