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)