Use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products

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Current effective version

Adopted guideline

Current version - see below

Reference numberCHMP/594085/2016
Effective from01/02/2017
KeywordsEpidemiologic cut-off value, exposure-response relationship, minimal inhibitory concentration, pharmacokinetic-pharmacodynamic index, magnitude, target, probability of target attainment, wild-type distribution
DescriptionThis document addresses the use of pharmacokinetic-pharmacodynamic analyses to identify potentially eficacious dose regimens of antibacterial agents. It applies also to antimycobacterial and antifungal agents.

Document history

Revision 1
Current version

Adopted guideline


Draft guideline


Overview of comments

Concept paper

In operation: 01/02/2017

Published: 28/02/2014

Published: 18/10/2016

First versionPoints to considerPublished: 27/07/2000

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