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GUIDANCE DOCUMENT

Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing March 2024

Download the Final Guidance Document
Final Level 1 Guidance
Docket Number:
FDA-2010-D-0133
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to assist sponsors planning to conduct studies to assess the influence of renal impairment on the pharmacokinetics of an investigational drug. It provides recommendations on when studies should be conducted to assess the influence of renal impairment on the pharmacokinetics of an investigational drug, the design of such studies, and how such studies should be carried out.

Additional Guidance Resources:

Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing Pharmacokinetics in Patients with Impaired Renal Function: Guidance Snapshot

Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing Pharmacokinetics in Patients with Impaired Renal Function: Guidance Recap Podcast

Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing Pharmacokinetics in Patients with Impaired Renal Function: Guidance Recap Podcast Transcript

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2010-D-0133 .

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