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

Keyword Search

Keyword Search Criteria: Biologics returned 9 record(s)
Sunday, 08/01/2010
Similarity Criteria for Follow-On Biologics Based on an Approach
Laszlo Endrenyi, University of Toronto
4:30 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.
4:55 PM

Monday, 08/02/2010
Transfer of Methods Supporting Biologics and Vaccines
Rong Liu, Merck & Co., Inc.; Timothy Schofield, GlaxoSmithKline; Jason Liao, Merck Research Laboratories


The Promise and Challenge of Benefit: Risk Analysis for Medical Products
Richard Forshee, FDA


Tuesday, 08/03/2010
Pharmacokinetics (PK) Comparability for Follow-On Biologics
Jason Liao, Merck Research Laboratories
2:25 PM

Evaluating Statistical Methods to Establish Clinical Similarity of Two Biologics: A Real-Life Example
Lei Lei, Amgen Inc.
2:45 PM

Considerations in the Development of Biologics and Biosimilars: A Case Study
Amy Ko, Merck & Co., Inc.
3:05 PM

Wednesday, 08/04/2010
Visualizing Risks, Benefits, and Uncertainty in Three Dimensions
Richard Forshee, FDA; Mark Walderhaug, FDA; Arianna Simonetti, FDA; Anne Fernando, Norfolk State University
8:50 AM

Thursday, 08/05/2010
Biomarkers in Clinical Trials in the Development of Biologics and Risk Assessment
Samir Lababidi, FDA
8:50 AM




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