Business · 22/03/2010
FDA Releases Revised Draft Guidance on Pharmacokinetics in Patients With Impaired Renal Function
The Food and Drug Administration (FDA) has made available a revised draft guidance for industry, which provides recommendations on assessing the influence of renal impairment on the pharmacokinetics of investigational drugs, and how to design and conduct such studies.
Original source language: Federal Register — Health and Human ServicesOpen original release →