Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled "Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage." This guidance assists sponsors in the design and analysis of studies that assess the influence of hepatic impairment on the pharmacokinetics and, where appropriate, the pharmacodynamics of a drug, including therapeutic biological products. When final, this guidance will represent FDA's current thinking. FDA is also withdrawing the guidance for industry titled "Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling" (May 2003), which formerly provided FDA's thinking relating to studies to assess the effect of hepatic impairment on the pharmacokinetics or pharmacodynamics of a drug and recommendations to include hepatic impairment information in labeling.

Abstract as published in the Federal Register.

The comment window is still open until December 1, 2026. The comment window is open. Check the document itself for what comments are being solicited on and what weight they carry. Submit comments through the Federal Register document below.