Zdrowie i gospodarka · 16/06/1997

FDA Releases Draft Guidance on Pharmacokinetics and Pharmacodynamics for Patients with Impaired Renal Function

The Food and Drug Administration (FDA) has made available a draft guidance document that outlines the requirements for studying the impact of renal impairment on the pharmacokinetics and pharmacodynamics of investigational drugs, with the goal of informing dosing and labeling decisions for these patients.