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Article Abstracts

Published:Journal of Chromatographic Science, ISSN 0021-9665Volume 44, Number 3, March 2006, pp. 119-122

Assessing the Reproducibility of an Analytical Method

Jason J.Z. Liao, Robert C. Capen, and Timothy L. Schofield
Merck Research Laboratories, P.O. Box 4, WP37C-305, West Point, PA 19486

The reproducibility of a validated analytical method may require reassessment because of various reasons, such as the transfer between laboratories or companies, changes in the instruments or software platforms (or both), or changes in critical reagents, among others. This paper is a demonstration of an assay bridging study in evaluating reproducibility. The approach is simple but very informative and offers many advantages over existing approaches.

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