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# Biomarker Bioanalytical Method Validation
- URL: https://www.fdaweb.com/biomarker-bioanalytical-method-validation/
- Published: 2025-01-21T12:00:00.000Z
- Updated: 2026-09-14T14:51:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158516

FDA has published a guidance, *Bioanalytical Method Validation for Biomarkers*, to help sponsors of INDs and applicants of NDAs, BLAs, sNDAs, sBLAs, and ANDAs to validate bioanalytical methods used to evaluate biomarker concentrations. The [document](https://www.fda.gov/media/185276/download?ref=fdaweb.com) says it can also inform the development of bioanalytical methods used to analyze biomarker concentrations in nonclinical study samples.

“The recommendations in this guidance pertain only to the validation of bioanalytical assays to measure in vivo biomarker concentrations in biological matrices such as blood or urine,” FDA says. “This guidance does not apply to bioanalytical method validations for the measurement of veterinary drug concentrations or veterinary biomarker concentrations.”

A 5/2018 guidance is being withdrawn with the publication of this document.