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Activity Details

179 Mon, 8/5/2013, 10:30 AM - 12:20 PM CC-514c
Topics in Bioequivalence and Biosimilarity — Contributed Papers
Biopharmaceutical Section
Chair(s): Stella Grosser, U. S. Food and Drug Administration
10:35 AM Stability Design and Analysis of Biosimilar Products Annpey Pong, Merck Research Laboratories ; Shein-Chung Chow, Duke University
10:50 AM Improved Biosimilar Design via Disease-Progression Model Russell Reeve, Quintiles ; Guochen Song, Quintiles ; Michael O'Kelly, Quintiles
11:05 AM Multiplicity Adjustment in Bioequivalence Using Two One-Sided Tests (TOST) Steven Hua, Pfizer Research ; Siyan Xu, Boston University ; Ronald Menton, Pfizer Inc.
11:20 AM Assessment of Exchangeability in Equivalence Trial Yi Tsong, FDA ; Xiaoyu Dong, FDA ; Meiyu Shen, FDA
11:35 AM A Comparison of Different Development Strategies and Study Designs for Device-Bridging Bioequivalence Studies Ying "Denise" Wang, Amgen ; Tony Sabin, Amgen, Inc
11:50 AM Sample-Size Determination for Equivalence Trial of Continuous Responses Yu-Wei Chang, Temple University ; Xiaoyu Dong, FDA ; Yi Tsong, FDA
12:05 PM Floor Discussion

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