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Activity Number: 246
Type: Contributed
Date/Time: Tuesday, August 8, 2006 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #305364
Title: Assessing the Reproducibility of an Analytical Method
Author(s): Jason Liao*+
Companies: Merck Research Laboratories
Address: P.O. Box 4, West Point, PA, 19486,
Keywords: validation ; reproducibility ; concordance ; agreement interval ; bias
Abstract:

A validated analytical method may need to be revalidated because of changes such as transfers between laboratories or analysts, changes in instruments and/or software platforms, or modifications. A fundamental parameter for this revalidation is the reproducibility of the method. In this paper, a method is proposed to define the agreement interval for each paired observation in assessing the overall concordance. The proposed approach is simple, but informative, and offers many advantages over existing approaches. It is demonstrated through an assay bridging study.

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