This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Activity Details

47 * Sun, 8/1/2010, 4:00 PM - 5:50 PM CC-223 (West)
Statistical Issues in Approval of Follow-On Biologics — Invited Papers
Biopharmaceutical Section , ENAR
Organizer(s): Eric M. Chi, Amgen Inc.
Chair(s): Shein-Chung Chow, Duke University School of Medicine
4:05 PM Bioequivalence and Variability Donald Schuirmann, FDA
4:30 PM Similarity Criteria for Follow-On Biologics Based on an Approach Laszlo Endrenyi, University of Toronto
4:55 PM Extended Nonparametric Tests for Evaluation of Biosimilarity in Variability to Assess Follow-On Biologics Nan Zhang, Amgen Inc. ; Jun Yang, Amgen Inc. ; Shein-Chung Chow, Duke University School of Medicine ; Eric M. Chi, Amgen Inc.
5:20 PM Discussant: Tony Lachenbruch, Oregon State University
5:40 PM Floor Discussion

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