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European Medicines Agency updates guidelines on drug interactions
Date: 11 Jul 2012
The European Medicine Agency (EMA) has finalised the update to its guidelines on the investigation of drug interactions.
The document outlines a comprehensive, systematic and mechanistic approach to the evaluation of the interaction potential of a drug during its development and offers guidance to ensure that the prescriber receives clear information on the interaction potential as well as practical recommendations on how the interactions should be managed during clinical use.
This update is a major revision of the previous document adopted in 1997 and brings the guidance in line with scientific advances in the investigation of drug interactions. This includes the use of physiologically-based pharmacokinetic (PBPK) modelling and simulation at different stages of drug development to inform study design and to assess the potential for, and effects of, drug interactions.
The updated guidelines, which come into effect on 1 January 2013, can be viewed here.