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

Current effective version

Guideline on the use of pharmacokinetics and pharmacodynamics in the development of antimicrobial medicinal products

Adopted Reference Number: EMA/CHMP/594085/2015 Legal effective date: 01/02/2017 Summary:

This Guideline replaces the Points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (CPMP/EWP/2655/99). The Guideline has been developed to outline the regulatory expectations for application dossiers and reflects both the scientific advances in the field that have implications for antimicrobial agent development programmes and the regulatory experience since the adoption of the 'Points to consider'.

Document history - Revision 1 (current)

Guideline on the use of pharmacokinetics and pharmacodynamics in the development of antimicrobial medicinal products

Adopted Reference Number: EMA/CHMP/594085/2015 Legal effective date: 01/02/2017 Summary:

This Guideline replaces the Points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (CPMP/EWP/2655/99). The Guideline has been developed to outline the regulatory expectations for application dossiers and reflects both the scientific advances in the field that have implications for antimicrobial agent development programmes and the regulatory experience since the adoption of the 'Points to consider'.

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)

Reference Number: EMA/242781/2016

Draft guideline on the use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products

Draft: consultation closed Consultation dates: 28/09/2015 to 31/03/2016 Reference Number: EMA/CHMP/594085/2015 Summary:

This guideline replaces the 'Points to consider' on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (CHMP/EWP/2655/99). The Guideline has been developed to outline the regulatory expectations for application dossiers and reflects both the scientific advances in the field of pharmacometrics that have implications for antimicrobial agent development programmes and the regulatory experience since the adoption of the 'Points to consider'.

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

Draft: consultation closed Consultation dates: 28/02/2014 to 31/05/2014 Reference Number: EMA/CHMP/792679/2013 Summary:

This concept paper proposes a revision of the CHMP’s points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (CPMP/EWP/2655/99) and its conversion into a full guideline.

Document history - First version

Points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products

Adopted Reference Number: CPMP/EWP/2655/99 Legal effective date: 01/02/2001