Clinical Pharmacology Corner

Today, the U.S. Food and Drug Administration (FDA) published the draft guidance entitled "Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage." This draft guidance replaces the May 2003 guidance entitled “Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling,” and when finalized, will represent FDA’s current thinking. 

Liver disease can lead to changes in a drug’s pharmacokinetics to a degree necessitating different recommendations for use of the drug in patients with hepatic impairment. This draft guidance is intended to provide recommendations to sponsors and applicants who plan to conduct studies to assess the influence of hepatic impairment on the pharmacokinetics and, where appropriate, pharmacodynamics of a drug, including therapeutic biological products.  

FDA seeks feedback on this draft guidance document. To ensure the FDA considers your comment, please submit your comments by December 1, 2026, to the docket (Docket No. FDA-2026-D-8693).