Issue Date: May 30, 2003
Issued by: Center for Biologics Evaluation and Research
Topic(s): Clinical – Pharmacology
Status: Final
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling
This guidance provides recommendations to sponsors and applicants who plan to conduct studies to assess the influence of hepatic impairment on the pharmacokinetics (PK) and, where appropriate, the pharmacodynamics (PD) of a drug, including therapeutic biological products.
Download the Guidance Document
