# Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/physiologically-based-pharmacokinetic-analyses-format-and-content-guidance-for-industry/a65eb174-50f7-4cfb-a751-33c206aaa385

> FDA guidance document: Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry. Issue date: September 04, 2018. Get complete insights and analysis.

---

## Details

- Title: Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2018-09-04
- Last Changed: 2021-01-26
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2016-D-3969">FDA-2016-D-3969</a>

## Related Documents

- [Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease](https://www.globalkeysolutions.net/guidances/guidance-document/developing-targeted-therapies-in-low-frequency-molecular-subsets-of-a-disease/becd1349-aa73-4de3-83cd-a43abfb0f98c)
- [Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format](https://www.globalkeysolutions.net/guidances/guidance-document/clinical-pharmacology-labeling-for-human-prescription-drug-and-biological-products-content-and-format/43229708-ad02-40d3-b318-996c20552a39)
- [Migraine: Developing Drugs for Acute Treatment](https://www.globalkeysolutions.net/guidances/guidance-document/migraine-developing-drugs-for-acute-treatment/39ba4b4b-6c93-4849-a087-866c6bf4edff)
