The
information in this final FDA guidance (“Bioanalytical Method
Validation
Guidance for Industry”) applies to bioanalytical procedures such as chromatographic
assays and ligand binding assays (LBAs) that quantitatively determine the levels
of drugs, their metabolites, therapeutic proteins, and biomarkers in biological
matrices such as blood, serum, plasma, urine, and tissue such as skin.
According
to FDA: “This guidance helps sponsors of investigational new drug applications
(INDs) or applicants of new drug applications (NDAs), abbreviated new drug
applications (ANDAs), biologic license applications (BLAs), and supplements
validate bioanalytical methods used in human clinical pharmacology,
bioavailability (BA), and bioequivalence (BE) studies that require pharmacokinetic,
toxicokinetic, or biomarker concentration evaluation. This guidance can also inform
the development of bioanalytical methods used for nonclinical studies that
require toxicokinetic or biomarker concentration data. For studies related to the
veterinary drug approval process such as investigational new animal drug applications
(INADs), new animal drug applications (NADAs), and abbreviated new animal drug
applications (ANADAs), this guidance may apply to blood and urine BA, BE, and
pharmacokinetic studies.”
Posted by Dr. Tim Sandle