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# Guidance on Pharmacokinetics in Patients with Impaired Renal Function
- URL: https://www.fdaweb.com/guidance-on-pharmacokinetics-in-patients-with-impaired-renal-function/
- Published: 2020-09-04T12:00:00.000Z
- Updated: 2026-09-14T16:27:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147588

*Federal Register* notice: FDA has made available a draft guidance entitled *Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing*. The document is intended to assist sponsors in the design and analysis of studies that assess the influence of impaired renal function on the pharmacokinetics and pharmacodynamics of an investigational drug and how such information can impact dosing. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-09-04/pdf/2020-19597.pdf?ref=fdaweb.com).