SOP 12: Validation of bioanalytical methods.

A bioanalytical method is a set of procedures involved in the collection, processing, storage, and analysis of a biological matrix for a chemical compound. The availability of selective and sensitive bioanalytical methods is a prerequisite for the generation of reliable data on pharmacokinetics, bioavailability, and bioequivalence of drugs. These methods should allow the quantification of drugs and their metabolites in biological matrices, e.g. plasma, urine, and cerebrospinal fluid, and must be validated with respect to their reliability for the intended use. Bioanalytical method validation comprises all criteria determining data quality, such as selectivity, accuracy, precision, recovery, sensitivity, and stability. This SOP is applicable for the analysis of preclinical as well as clinical samples. A specific, unique chemical moiety that would be found in a biological matrix is referred to as analyte.