Validation of chromatographic methods in biomedical analysis. Viewpoint and discussion.
Bioanalytical method validation is the process used to establish that a quantitative analytical method is suitable for biomedical applications. Reassurances as to the quality of the method and its reliability come from adopting a minimum series of validation experiments and obtaining satisfactory results. Consistent evaluation of the key analytical parameters: recovery, response function, sensitivity, precision, accuracy, selectivity and stability, is discussed with a view to improving scientific standards in manuscripts submitted for publication.
Causon
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GlaxoWellcome Research and Development, Beckenham, Kent, UK.
D002845:Chromatography / Q000379:methods*; D006801:Humans; D011786:Quality Control; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity