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# Renal PK Study Guidance
- URL: https://www.fdaweb.com/renal-pk-study-guidance/
- Published: 2024-03-19T12:00:00.000Z
- Updated: 2026-09-14T14:25:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156586

FDA has published a guidance, *Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing*, to assist sponsors in designing and analyzing studies assessing the influence of impaired renal function on the pharmacokinetics (PK) and/or pharmacodynamics of an investigational drug. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pharmacokinetics-patients-impaired-renal-function-study-design-data-analysis-and-impact-dosing?ref=fdaweb.com) also provides recommendations on determining the recommended dosage in patients with impaired renal function and addresses how such information can inform the labeling, including:

- when a standalone study to address a drug’s PK in participants with impaired renal function is recommended and when it may not be warranted
- the design and conduct of PK studies in participants with impaired renal function;
- considerations for characterizing a drug’s PK in patients receiving intermittent or continuous renal replacement therapies;
- using information from Phase 2 and 3 studies to characterize the impact of renal function on PK and/or drug effects in patients with impaired renal function;
- considerations for deriving dosage recommendations for patients with impaired renal function; and
- analysis and reporting of study results that characterize the impact of impaired renal function and how these data inform dosing recommendations in labeling.