# The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls : Draft Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/the-use-of-physiologically-based-pharmacokinetic-analyses-biopharmaceutics-applications-for-oral-drug-product-development-manufacturing-changes-and-controls-draft-guidance-for-industry/1478d7de-3011-4521-8336-5e9803457e9e

> FDA guidance document: The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls : Draft Guidance for Industry. Issue date: September 30, 2020. Get complete insights and analysis.

---

## Details

- Title: The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls : Draft Guidance for Industry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: 2020-09-30
- Comment Close Date: 2020-11-30
- Last Changed: 2020-09-30
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2020-D-1517">FDA-2020-D-1517</a>

## Related Documents

- [Establishing Impurity Specifications for Antibiotics](https://www.globalkeysolutions.net/guidances/guidance-document/establishing-impurity-specifications-for-antibiotics/5bb8badb-7c32-4b76-bfc9-bbb8ab55fb84)
- [Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications : Draft Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/assessment-of-adhesion-for-topical-and-transdermal-systems-submitted-in-new-drug-applications-draft-guidance-for-industry/2c6ec6df-cd19-4af8-ac74-0ccd1281b8ef)
- [How To Obtain a Covered Product Authorization](https://www.globalkeysolutions.net/guidances/guidance-document/how-to-obtain-a-covered-product-authorization/881f0322-95f9-4bfd-b6c3-35f5df950808)