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USFDA Guidance: Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling
The U.S. Food and Drug Administration (FDA) has issued the September 2026 draft guidance “Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling”. The guidance provides recommendations for sponsors and applicants planning studies to evaluate how hepatic impairment affects the pharmacokinetics (PK) and, where appropriate, pharmacodynamics (PD) of drugs, including therapeutic biological products. It is a draft
Sharan Murugan
19 hours ago4 min read