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Legend: Palais des congrès de Montréal = CC, Le Westin Montréal = W, Intercontinental Montréal = I
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Activity Details

487 Wed, 8/7/2013, 8:30 AM - 10:20 AM CC-512c
Challenges in the Evaluation of Biologics — Contributed Papers
Biopharmaceutical Section , Biometrics Section
Chair(s): Judy Li, FDA
8:35 AM Determination of Bioassay Cut Point Using Confidence Limit of Percentile Meiyu Shen, FDA ; Xiaoyu Dong, FDA ; Youngsook Jeon, FDA ; Yi Tsong, FDA
9:05 AM Modeling and Interpretation of Vaccine Cross-Over Clinical Trials Data Scott Patterson ; Byron Jones, Novartis Pharma AG ; Michael Kenward, University of London
9:20 AM Two-Threshold Model for Immunological Correlates of Protection Hongbo Lin ; Fabrice Bailleux, Sanofi Pasteur ; Xuan Chen, Sanofi Pasteur ; Kamal Desai, Imperial College ; Andrew Dunning, Sanofi Pasteur
9:35 AM Predicting Vaccine Efficacy Based on Associations Among Disease, Immune Responses, and Treatment Lihan Yan, FDA
9:50 AM Assessment of Biosimilar Products Using a Biosimilarity Index Based on a Tolerance Interval Approach Chinfu Hsiao, National Health Research Institutes ; Hsiao-Hui Tsou, National Health Research Institutes
10:05 AM Simultaneous Joint and Marginal Models Approach for Testing Multivariate Binomial Data — Shuling Liu, Emory University ; Kerry Go, Sanofi Pasteur ; Manoj Thakur, Sanofi Pasteur

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