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A comprehensive method validation strategy for bioanalytical applications in the pharmaceutical industry--1.
1Department of Clinical Pharmacokinetics, Glaxo Inc., Research Triangle Park, NC 27709.
Journal of Pharmaceutical and Biomedical Analysis
|January 1, 1991
Abstract:
The method validation strategy described consists of four components which are the prevalidation, validation proper, study proper and statistical analyses. These components constitute the platform upon which to evaluate the reliability and reproducibility of a bioanalytical method. Consideration has been given to emulate the study proper conditions to understand the method's limitations and performance expectations. The validation strategy will be presented in two papers. This first paper will describe the overall validation strategy, and the second paper will discuss the statistical analyses and data interpretation.