Method validation across the disciplines--critical investigation of major validation criteria and associated experimental protocols.
Analytical method development should aim at delivering reliable measurements within a given application. This implies that method validation is integrated in the development process, because it enables to establish a method's performance capabilities, and to demonstrate its fitness-for-purpose. Although analytical chemists mostly are familiar with the validation guidelines within the discipline of their responsibility, we believe that they may take advantage of a better acquaintance with recommendations among disciplines. Therefore, we review the guidance given in 4 disciplines (laboratory medicine, pharmacy, environment, and food), with emphasis on the proposed experimental protocols, acceptance criteria and interpretation strategies by statistical significance testing. Last but not least, we give incentive towards a modernized validation design.
Stöckl
Dietmar
D
Laboratory for Analytical Chemistry, Faculty of Pharmaceutical Sciences, Gent University, Harelbekestraat 72, B-9000 Gent, Belgium.
D'Hondt
Heidi
H
Thienpont
Linda M
LM
D002621:Chemistry / Q000379:methods / Q000592:standards*; D017408:Guidelines as Topic / Q000592:standards*; D054928:Validation Studies as Topic