Zdrowie i gospodarka · 07/12/1999

Draft Guidance for Industry on Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling.'' This draft guidance provides recommendations to sponsors planning to conduct studies to assess the influence of hepatic impairment on the pharmacokinetics and, where appropriate, the pharmacodynamics of drugs or therapeutic biologics.