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Legend: Boston Convention & Exhibition Center = CC, Westin Boston Waterfront = W, Seaport Boston Hotel = S
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Activity Details

335 * Tue, 8/5/2014, 10:30 AM - 12:20 PM CC-153B
Assessing Biosimilar and Equivalence — Contributed Papers
Biopharmaceutical Section
Chair(s): John Scott, FDA/CBER/OBE   
10:35 AM Assessing Biosimilarity of a Follow-On Biologics Hsiao-Hui Tsou, National Health Research Institutes ; Chinfu Hsiao, National Health Research Institutes ; Chi-Tian Chen, National Health Research Institutes ; Yi-Hsuan Lai, Delta Electronics
10:50 AM Testing Hypotheses of Nonzero Differences in Means: From Westlake to Wellek, and Future Research Prospects Kallappa Koti, FDA
11:05 AM Inference of Equivalence for the Ratio of Two Normal Means with Unspecified Variances Siyan Xu ; Steven Y. Hua, Pfizer ; Ronald Menton, Novartis ; Kerry Barker, Pfizer ; Sandeep Menon, Pfizer ; Ralph D'Agostino Sr., Boston University
11:20 AM The STEPP Approach to Assessing Treatment-Effect Heterogeneity for Relative and Absolute Endpoints Ann Lazar, University of California, San Francisco ; Marco Bonetti, Bocconi University ; Bernard F. Cole, University of Vermont ; Wai-ki Yip, Harvard School of Public Health ; Richard D. Gelber, Harvard School of Public Health/Dana-Farber Cancer Institute
11:35 AM Control of FWER Using Close Testing for 3-Arm PK Similarity Trials Steven Y. Hua, Pfizer ; Ray Li, Pfizer ; Kerry Barker, Pfizer ; Siyan Xu ; Christy Chuang-Stein, Pfizer ; Shan Mei Liao, Pfizer
11:50 AM Floor Discussion

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