Zdrowie i gospodarka · 15/05/1998

Guidance for Industry on Pharmacokinetics in Patients with Impaired Renal FunctionStudy Design, Data Analysis, and Impact on Dosing and Labeling; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Pharmacokinetics in Patients with Impaired Renal Function--Study Design, Data Analysis, and Impact on Dosing and Labeling.'' The guidance is intended for sponsors planning to conduct studies to assess the influence of renal impairment on the pharmacokinetics of an investigational drug.