Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling

Docket Number:: FDA-1999-D-0063
Issued by:: Guidance Issuing Office

Center for Biologics Evaluation and Research

Center for Drug Evaluation and Research

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.

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Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling

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