The Food and Drug Administration (FDA), European Medicinal Agency (EMA), and International Consortium for Harmonization (ICH) have issued guidances that are intended to provide recommendations for the validation of bioanalytical assays for chemical and biological drug quantification and their application in the analysis of study samples.
Type of Bioanalytical Method Validation
Bioanalytical method validation is essential to ensure the acceptability of assay performance and the reliability of analytical results. A bioanalytical method is defined as a set of procedures used for measuring analyte concentrations in biological samples.
Full validation of a bioanalytical method should be performed when establishing a bioanalytical method for the quantification of an analyte in clinical and in pivotal nonclinical studies. Full validation should also be performed when implementing an analytical method that is reported in the literature and when a commercial kit is repurposed for bioanalytical use in drug development.
A specific, detailed, written description of the bioanalytical method should be established a priori. This description may be in the form of a protocol, study plan, report, or Standard Operating Procedure (SOP).
Modifications to a fully validated analytical method may be evaluated by partial validation. Partial validation can range from as little as one accuracy and precision determination to nearly full validation. The items in a partial validation are determined according to the extent and nature of the changes made to the method.
Where data are obtained from different methods within or across studies, or when data are obtained within a study from different laboratories applying the same method, comparison of those data is needed and cross-validation of the applied analytical methods should be carried out.