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# Pharmacokinetics for Impaired Renal Function Guidance
- URL: https://www.fdaweb.com/pharmacokinetics-for-impaired-renal-function-guidance/
- Published: 2020-09-03T12:00:00.000Z
- Updated: 2026-09-14T16:27:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147584

FDA has issued a draft guidance, *Pharmacokinetics in Patients with Impaired Renal Function—Study Design, Data Analysis, and Impact on Dosing*, to assist sponsors in the design and analysis of studies assessing the influence of impaired renal function on pharmacokinetics and/or pharmacodynamics of an investigational drug. The [document](https://www.fda.gov/media/78573/download?ref=fdaweb.com) also addresses how such information can inform the drug’s labeling.

The draft revises and replaces a 3/2010 draft guidance and provides updated recommendations on: 

- when a standalone study of a drug’s pharmacokinetics in subjects with impaired renal function is recommended and when it may not be needed;
- the design and conduct of pharmacokinetic studies in subjects with impaired renal function;
- considerations for characterizing a drug’s pharmacokinetics in patients undergoing intermittent or continuous dialytic therapies;
- the use of pharmacokinetic information from Phase 2 and 3 studies to inform dosing recommendations for patients with impaired renal function; and
- the analysis and reporting of the results of studies that characterize the impact of impaired renal function and how these data inform dosing recommendations in labeling.