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Activity Details


343 * Tue, 7/31/2012, 10:30 AM - 12:20 PM CC-Room 27B
Selected Analysis and Bioequivalence — Contributed Papers
Biopharmaceutical Section
Chair(s): Jin Xu, Merck
10:35 AM Optimizing Bioequivalence Trial Sample Size Bret Musser, Merck ; Junghoon Lee, Merck ; Larson Patrick, Merck
10:50 AM Designs for Bayesian Adaptive Bioequivalence Trials Cheng Zheng, Novartis ; Jixian Wang, Novartis
11:05 AM Group Sequential Method for PK Bioequivalence Crossover Studies Huaixiang Li, FDA/OTS/CDER/OB/DBG ; Stella Grosser, FDA/CDER
11:20 AM On the Asymmetrical Margins Approach to Biosimilarity Clinical Trials with Efficacy Endpoints Yulan Li, Novartis ; Qing Liu, Johnson & Johnson
11:35 AM Operating Characteristics in Assessing Agreement Between Two Instruments of Quantitative Measurement Jeng Mah, Beckman Coulter
11:50 AM A Statistical Approach to Determining the Minimum Bead Number for Luminex Bead--Based Assays Yuan (Sally) Zhang, Boehringer Ingelheim Pharmaceuticals, Inc. ; Xiaoyu Jiang, Novartis Institutes for BioMedical Research ; Shuguang Huang, Precision Therapeutics, Inc.
12:05 PM Floor Discussion



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