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# Bioanalytical Methods Template Available
- URL: https://www.fdaweb.com/bioanalytical-methods-template-available/
- Published: 2019-10-03T12:00:00.000Z
- Updated: 2026-09-15T01:54:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145159

FDA says a “*Bioanalytical Methods Template*” technical specifications guidance is available for industry to use. An agency [notice](http://s2027422842.t.en25.com/e/es?s=2027422842&e=261125&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=c230ce9465d44438becd38dc1655f6e4&elqaid=9740&elqat=1&ref=fdaweb.com) says the [guidance](https://www.fda.gov/media/131425/download?ref=fdaweb.com) provides ready-to-use templates that sponsors can use to submit summaries of bioanalytical methods used in clinical pharmacology studies that require pharmacokinetic concentration evaluation. Templates in the guidance are applicable to bioanalytical procedures such as chromatographic assays and ligand-binding assays that quantitatively determine the levels of drugs and their metabolites and therapeutic proteins in biological matrices such as blood, serum, plasma, urine, and tissue such as skin.

FDA says the templates may be used for NDAs, BLAs, and supplements to these applications to provide information about the bioanalytical methods for pharmacokinetic assessments.