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# Guidance on Impaired Renal Function Pharmacokinetics
- URL: https://www.fdaweb.com/guidance-on-impaired-renal-function-pharmacokinetics/
- Published: 2020-09-08T12:00:00.000Z
- Updated: 2026-09-14T16:27:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147598

FDA has made availabile a revised [draft guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pharmacokinetics-patients-impaired-renal-function-study-design-data-analysis-and-impact-dosing-and?ref=fdaweb.com) on *Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing*. The document is intended to assist sponsors in designing and analyzing drug studies that assess the influence of impaired renal function on pharmacokinetics and pharmacodynamics, and it addresses how such information can inform product labeling. FDA says that if a drug is eliminated primarily through renal excretion, then impaired renal function can change a drug’s pharmacokinetics that could necessitate a change in the dosing regimen from that used in patients with normal renal function. It notes that individuals with advanced renal disease are frequently excluded from late-phase clinical trials, “hindering the determination of a safe and effective dosing regimen for this patient population. A well-planned drug development program can enable prospective dosage adjustment based on the observed or expected changes in the pharmacokinetics of a drug due to impaired renal function prior to initiating Phase 2 or Phase 3 trials.”

The guidance also updates recommendations on: (**1**) when a standalone study of a drug’s pharmacokinetics in subjects with impaired renal function is recommended; (**2**) the design and conduct of pharmacokinetic studies in subjects with renal impairment; (**3**) considerations for characterizing a drug’s pharmacokinetics in patients undergoing dialytic therapies; (**4**) the use of pharmacokinetic information from Phase 2 and 3 studies to inform dosing recommendations for patients with renal impairment; and (**5**) the analysis and reporting of results from studies that characterize the impact of renal impairment and how these data inform dosing.