GLP-compliant assay validation studies: considerations for implementation of regulations and audit of studies

Bioanalytical methods used in nonclinical safety studies are validated to demonstrate that the methods are reliable and reproducible for the intended use. Analytical method validation studies should be designed according to regulatory guidance on method validation. A cell-based assay is described to discuss fundamental validation parameters, such as repeatability, immediate precision, accuracy, and linearity. A Good Laboratory Practice (GLP) compliance program provides a useful platform for ensuring data integrity in assay validation studies. A good understanding of the method validation concepts and regulatory requirements will help Quality Assurance Unit (QAU) auditors focus on key areas and be more effective when auditing assay validation protocols, final reports, and associated data. Copyright © 2006 John Wiley & Sons, Ltd.