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Zdrowie i gospodarka · 18/03/2024

FDA Releases Final Guidance on Pharmacokinetics in Patients with Impaired Renal Function

The US Food and Drug Administration (FDA) has released a final guidance for industry on pharmacokinetics in patients with impaired renal function, aiming to improve dosing recommendations for approved drugs. The guidance finalizes a draft issued in 2020 and provides guidance for sponsors on study design and data analysis.

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