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# Draft Guidance on Pharmacokinetic Analyses Format/Content
- URL: https://www.fdaweb.com/draft-guidance-on-pharmacokinetic-analyses-format-content/
- Published: 2016-12-01T12:00:00.000Z
- Updated: 2026-09-14T21:52:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137468

FDA has released a [draft guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM531207.pdf?ref=fdaweb.com) on “Physiologically Based Pharmacokinetic Analyses — Format and Content” that outlines the recommended format and content for a sponsor to submit physiologically based pharmacokinetic (PBPK) analyses to support applications. To enable efficient and consistent review, the document recommends including the following five sections in a PBPK study report: (**1**) Executive Summary; (**2**) Materials and Methods; (**3**) Results; (**4**) Discussion; and (**5**) Appendices. The content of each section is described in the guidance, however it 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 (i.e., both small molecules and biologics). “The decision to accept results from PBPK analyses in lieu of clinical pharmacokinetic (PK) data is made on a case-by-case basis, taking into account the intended use for the analyses, as well as the quality, relevance, and reliability of the study results,” it says.