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

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Download document 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
Reference number EMA/CHMP/792679/2013
Status draft: consultation open
First published 28/02/2014
Last updated 28/02/2014
Consultation start date 28/02/2014
Consultation end date 31/05/2014
Email address for submissions idwpsecretariat@ema.europa.eu

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.