FDA Reissues Bioanalytical Method Validation Guidance

FDA has updated a 2001 guidance on bioanalytical method validation because of advances in bioanalytical technology and science. Guidance for Industry, Bioanalytical Method Validation, Draft Guidance provides general recommendations for bioanalytical method validation that may be modified depending on the type of method used. The draft offers guidance on the development of bioanalytical method validation information used in human clinical pharmacology, bioavailability (BA), and bioequivalence (BE) studies that require pharmacokinetic (PK) or biomarker concentration evaluation for investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologic license applications (BLAs), and supplements.

The guidance applies to gas chromatography (GC); high-pressure liquid chromatography (LC); combined GC and LC mass spectrometric (MS) procedures, such as LC-MS, LC-MS-MS, GC-MS, and GC-MS-MS; and ligand binding assays (LBAs), and immunological and microbiological procedures that are performed for the quantitative determination of drugs and/or metabolites, and therapeutic proteins in biological matrices, such as blood, serum, plasma, urine, tissue, and skin.