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Zdrowie i gospodarka · 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FDA Releases Revised Draft Guidance on Pharmacokinetics in Patients With Impaired Renal Function

The Food and Drug Administration (FDA) has made available a revised draft guidance for industry, which provides recommendations on assessing the influence of renal impairment on the pharmacokinetics of investigational drugs, and how to design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.

Source: Federal Register — Health and Human ServicesOpen original release →