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.