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# Guide on Using Physiologically Based Pharmacokinetic Analyses
- URL: https://www.fdaweb.com/guide-on-using-physiologically-based-pharmacokinetic-analyses/
- Published: 2020-10-01T12:00:00.000Z
- Updated: 2026-09-14T16:31:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147781

*Federal Register* notice: FDA has made available a draft guidance entitled *The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls.* The document provides general recommendations about the development, evaluation, and use of physiologically based pharmacokinetic analyses for biopharmaceutics applications used in INDs, NDAs, ANDAs and application supplements. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-10-01/pdf/2020-21652.pdf?ref=fdaweb.com).