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

Activity Details

393 * Tue, 8/3/2010, 2:00 PM - 3:50 PM CC-217 (West)
Biosimilarity for Follow-On Biologics — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Jason Liao, Merck Research Laboratories
Chair(s): Rong Liu, Merck & Co., Inc.
2:05 PM Issues and Challenges in the Clinical Development of Biosimilars Patrick FitzGerald Darken, Teva Branded Pharmaceutical Product R&D, Inc. ; Steve Barash, Teva Branded Pharmaceutical Product R&D, Inc.
2:25 PM Pharmacokinetics (PK) Comparability for Follow-On Biologics Jason Liao, Merck Research Laboratories
2:45 PM Evaluating Statistical Methods to Establish Clinical Similarity of Two Biologics: A Real-Life Example Lei Lei, Amgen Inc.
3:05 PM Considerations in the Development of Biologics and Biosimilars: A Case Study Amy Ko, Merck & Co., Inc.
3:25 PM Discussant: Stella Grosser, FDA
3:45 PM Floor Discussion



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