> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Guide on Bioanalytical Method Validation
- URL: https://www.fdaweb.com/fda-guide-on-bioanalytical-method-validation/
- Published: 2018-05-21T12:00:00.000Z
- Updated: 2026-09-15T00:06:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141486

FDA has posted a [guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070107.pdf?ref=fdaweb.com) entitled “Bioanalytical Method Validation” that discusses validating bioanalytical methods used in human clinical pharmacology, bioavailability, and bioequivalence studies that require pharmacokinetic, toxicokinetic, or biomarker concentration evaluation. The document can also inform the development of bioanalytical methods used for nonclinical studies that require toxicokinetic or biomarker concentration data. It applies to bioanalytical procedures such as chromatographic assays and ligand binding assays that quantitatively determine the levels of drugs, their metabolites, therapeutic proteins, and biomarkers in biological matrices such as blood, serum, plasma, urine, and tissues.