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.