Are You Validating Methods for Bioanalytical Samples?

In previous columns I have mainly discussed aspects of method validation for product analysis performed in quality control (QC) laboratories, but not for bioanalytical methods. To be specific, a bioanalytical method in the context of this column is the analysis of small drug molecules and any metabolites in biological samples generated from non-clinical and clinical studies. The data generated from these studies are used to evaluate the pharmacokinetics, bioavailability, bioequivalence and toxicokinetics, which are used to support regulatory submissions of new drugs or licensing generic versions of existing drugs.