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# Draft Guide on Pharmacokinetic Analyses Format and Content
- URL: https://www.fdaweb.com/draft-guide-on-pharmacokinetic-analyses-format-and-content/
- Published: 2016-12-02T12:00:00.000Z
- Updated: 2026-09-14T21:52:03.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137483

*Federal Register* Notice: FDA has released a draft guidance on “Physiologically Based Pharmacokinetic Analyses — Format and Content.” The document recommends the format and content for submitting physiologically-based pharmacokinetic analyses to FDA to enable efficient and consistent reviews. To view the guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM531207.pdf?ref=fdaweb.com). To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-02/pdf/2016-28971.pdf?ref=fdaweb.com).