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

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Current effective version

Adopted guideline

Reference numberEMA/83874/2014
Published02/02/2016
Effective from01/07/2016
KeywordsPharmacokinetics, 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)
DescriptionThis document gives recommendation on situations when studies of pharmacokinetics should be performed in subjects with decreased renal funtion. 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.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/07/2016–present


Published: 02/02/2016


Published: 28/02/2014


Published: 08/02/2012

Superseded documentAdopted guidelineIn operation: 01/12/2004–01/07/2016


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