Use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products - Scientific guideline
This 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.
Keywords: Epidemiologic cut-off value, exposure-response relationship, minimal inhibitory concentration, pharmacokinetic-pharmacodynamic index, magnitude, target, probability of target attainment, wild-type distribution
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Guideline on the use of pharmacokinetics and pharmacodynamics in the development of antimicrobial medicinal products (PDF/198.71 KB)
Adopted
First published: 26/07/2016
Last updated: 26/07/2016
Legal effective date: 01/02/2017
EMA/CHMP/594085/2015 -
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Overview of comments received on 'Draft guideline on the use of pharmacokinetics and pharmacodynamics in the development of antimicrobial medicinal products’ (EMA/CHMP/594085/2015) (PDF/470.9 KB)
First published: 18/10/2016
Last updated: 18/10/2016
EMA/242781/2016 -
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Draft guideline on the use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (PDF/219.68 KB)
Draft: consultation closed
First published: 28/09/2015
Last updated: 28/09/2015
Consultation dates: 28/09/2015 to 31/03/2016
EMA/CHMP/594085/2015 -
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Draft concept paper on revision of the points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (CHMP/EWP/2655/99) and conversion to a CHMP guideline (PDF/100.98 KB)
Draft: consultation closed
First published: 28/02/2014
Last updated: 28/02/2014
Consultation dates: 28/02/2014 to 31/05/2014
EMA/CHMP/792679/2013