# Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/pharmacokinetics-in-patients-with-impaired-hepatic-function-study-design-data-analysis-and-impact-on-dosing-and-labeling/578ee829-2b5f-40bd-8dca-59c140a08ef9 > FDA guidance document: Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling. Issue date: May 30, 2003. Get complete insights and analysis. --- ## Details - Title: Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling - 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: 2003-05-30 - Last Changed: 2025-01-31 - Docket Number: FDA-1999-D-0063 ## Related Documents - [Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment: Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/good-pharmacovigilance-practices-and-pharmacoepidemiologic-assessment-guidance-for-industry/9fb2afd0-d696-4043-9e1d-40673dcaf63a) - [Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications](https://www.globalkeysolutions.net/guidances/guidance-document/exposure-response-relationships-study-design-data-analysis-and-regulatory-applications/e3b78410-ce8b-46f8-9ae8-b9df1485d11e) - [Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products--Chemistry, Manufacturing, and Controls Documentation: Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/nasal-spray-and-inhalation-solution-suspension-and-spray-drug-products-chemistry-manufacturing-and-controls-documentation-guidance-for-industry/39c6d463-15aa-443b-847e-8eb8baa08474)