JSM 2013 Home
Online Program Home
My Program

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.

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



2013 JSM Online Program Home

For information, contact jsm@amstat.org or phone (888) 231-3473.

If you have questions about the Continuing Education program, please contact the Education Department.

The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.

ASA Meetings Department  •  732 North Washington Street, Alexandria, VA 22314  •  (703) 684-1221  •  meetings@amstat.org
Copyright © American Statistical Association.