Evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function - Scientific guideline

This document gives recommendation on situations when studies of pharmacokinetics should be performed in subjects with decreased renal function. It provides guidance on the design of such studies as well as data presentation, analysis, evaluation of results and reflection of those results in the summary of product characteristics.

Keywords: Pharmacokinetics, renal impairment, renal function, renal elimination capacity, kidney, elimination, phase I, glomerular filtration rate (GFR), end-stage renal disease, dialysis, summary of product characteristics, physiologically-based pharmacokinetic modelling (PBPK)

Current effective version

Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function

Adopted Reference Number: EMA/CHMP/725881/2015 Legal effective date: 01/07/2016

Document history - First version (current)

Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function

Adopted Reference Number: EMA/CHMP/725881/2015 Legal effective date: 01/07/2016

Overview of comments received on Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function (EMA/CHMP/ 83874/2014)

Reference Number: EMA/CHMP/725881/2015

Draft guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function

Draft: consultation closed Consultation dates: 01/03/2014 to 31/08/2014 Reference Number: EMA/83874/2014 Summary:

Pharmacokinetic studies can be used to estimate drug exposure in subpopulations of patients with characteristics that might affect the pharmacokinetics of the drug, and alternative dosing regimens may be developed based on the degree of change in exposure and the pharmacokinetic/pharmacodynamic (PK/PD) relationship. Pharmacokinetic data can, thus, be used to extrapolate efficacy and safety data from the phase III population to subpopulations that were not sufficiently represented in the phase III study.

Concept paper on the need for revision of the note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function

Draft: consultation closed Consultation dates: 08/06/2012 to 31/07/2012 Reference Number: EMA/CHMP/203926/2012 Summary:

The note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function (CHMP/EWP/225/02) provides recommendations on when to conduct pharmacokinetic studies in patients with reduced renal function, design and evaluation of such studies and how to develop dosage recommendations in patients with renal impairment. This concept paper discusses the need to revise some sections of the guideline.

Document history - Superseded document

Note for guidance on the evaluation of the pharmacokinetics of medical products in patients with impaired renal function

Adopted Reference Number: CHMP/EWP/225/02 Legal effective date: 01/12/2004