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# Pharmacokinetic Analyses Format and Content Guidance
- URL: https://www.fdaweb.com/pharmacokinetic-analyses-format-and-content-guidance/
- Published: 2018-09-04T12:00:00.000Z
- Updated: 2026-09-15T00:29:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142250

FDA has published a guidance, *Physiologically Based Pharmacokinetic Analyses—Format and Content*, to outline the recommended format and content for a sponsor or applicant to submit physiologically based pharmacokinetic (PBPK) analyses to FDA to support applications including NDAs, BLAs, or ANDAs. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM531207.pdf?ref=fdaweb.com) says the agency recommends including these six sections to enable efficient and consistent review: executive summary, introduction, materials and methods, results, discussion, and appendices. The guidance describes the content of each section in detail.

The guidance does not address methodological considerations and best practices for conducting PBPK modeling and simulation or the appropriateness of PBPK analyses for a particular drug or a drug product. “The decision to accept results from PBPK analyses in lieu of clinical pharmacokinetic data is made on a case-by-case basis,” it says, “considering the intended uses, as well as the quality, relevance, and reliability of the results from the PBPK analyses.”