Investigation of drug interactions - Scientific guideline
This document provides advice and recommendations on how to evaluate the potential for drug-food and drug-drug interactions for medicinal products (including herbal medicinal products) and how to translate the results of these evaluations to appropriate treatment recommendations in the labelling.
Keywords: Interaction, metabolism, inhibition, induction, transport, enzyme, transport protein, transporter, absorption, food, distribution, physiologically based pharmacokinetic (PBPK), herbal, summary of product characteristics (SmPC), pharmacodynamic
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Guideline on the investigation of drug interactions - Revision 1 (PDF/829.31 KB)
Adopted
First published: 06/07/2012
Last updated: 03/06/2015
CPMP/EWP/560/95/Rev.1 Corr.2** -
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Overview of comments received on guideline on the investigation of drug interactions (PDF/1.33 MB)
First published: 02/08/2013
Last updated: 02/08/2013
EMA/CHMP/EWP/125211/2010 -
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Draft guideline on the investigation of drug interactions (PDF/351.7 KB)
Draft: consultation closed
First published: 30/04/2010
Last updated: 04/05/2010
Consultation dates: 22/04/2010 to 31/10/2010
EMA/CHMP/EWP/125211/2010 -
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Concept paper/recommendation on the need for revision of (CHMP) note for guidance on the investigation of drug interactions (PDF/30.68 KB)
First published: 24/07/2008
Last updated: 24/07/2008
EMEA/CHMP/EWP/297931/2008