Legend: Palais des congrès de Montréal = CC, Le Westin Montréal = W, Intercontinental Montréal = I
A * preceding a session name means that the session is an applied session.
A ! preceding a session name means that the session reflects the JSM meeting theme.
A * preceding a session name means that the session is an applied session.
A ! preceding a session name means that the session reflects the JSM meeting theme.
Activity Details
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| 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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