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

Abstract Details

Activity Number: 256
Type: Contributed
Date/Time: Monday, August 2, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #308588
Title: Transfer of Methods Supporting Biologics and Vaccines
Author(s): Rong Liu*+ and Timothy Schofield and Jason Liao
Companies: Merck & Co., Inc. and GlaxoSmithKline and Merck Research Laboratories
Address: 770 Summeytown Pike, Westpoint, PA, 19486, USA
Keywords: Analytical method transfer ; Equivalence test ; Total error approach

The transfer of analytical methods supporting biologics and vaccines is complicated by the complexity and variability of biological systems. Many of these assays may be linked to clinical performance, and thus subject to specifications that have been established from materials that were tested in the development laboratory. Thus transfer must account for the risk that the method characteristics have changed, and may generate results for commercial lots that either earmark a satisfactory lot as failing, or an unsatisfactory lot as passing specification. Transfer study strategies have been proposed based on method parameters or on tolerance intervals. This presentation will describe a framework for establishing the equivalence between two laboratories with emphasis on the associated risks, and compare and contrast the parametric and tolerance approaches.

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