# Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing – FDA Guidance

Source: https://www.keypedia.com/guidances/guidance-document/pharmacokinetics-in-patients-with-impaired-hepatic-function-study-design-data-analysis-and-impact-on-dosing/a6613274-1ed5-414e-b72d-168058dfe307

> FDA guidance document: Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing. Issue date: September 02, 2026. Get complete insights and analysis.

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## Details

- Title: Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing
- 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: 2026-09-02
- Comment Close Date: 2026-12-01
- Last Changed: 2026-10-07
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2026-D-8693">FDA-2026-D-8693</a>

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