Pharmacokinetics in Patients With Impaired Renal Function-Study Design, Data Analysis, and Impact on Dosing; Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Pharmacokinetics in Patients with Impaired Renal Function--Study Design, Data Analysis, and Impact on Dosing." In general, drug development programs should be conducted so that when products are approved, the labeling provides appropriate dosing recommendations for patients with renal impairment. This guidance is intended to assist sponsors in the design and analysis of studies that assess the influence of impaired renal function on the pharmacokinetics (PK) and/ or pharmacodynamics (PD) of an investigational drug and addresses how such information can inform the labeling. This guidance finalizes the draft guidance "Pharmacokinetics in Patients with Impaired Renal Function--Study Design, Data Analysis, and Impact on Dosing" issued on September 4, 2020.
Abstract as published in the Federal Register.
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