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Zdrowie i gospodarka · 07/12/1999

FDA Releases Draft Guidance on Pharmacokinetics in Patients with Impaired Liver Function

The Food and Drug Administration (FDA) has made available a draft guidance document that provides recommendations for industry sponsors on how to design and analyze studies to assess the impact of liver impairment on drug efficacy and dosing.

Source: Federal Register — Food and Drug AdministrationOpen original release →