Guideline on the Investigation of Drug Interactions

The EMEA Guideline on Investigation of Drug Interactions from April 2010

The potential for interactions between new medicinal products and already marketed drugs should be evaluated. This applies both to effects of the medicinal product on other drugs as well as the effect of other drugs on the medicinal product. Furthermore the effect of concomitant food intake needs to be investigated. The interaction potential is usually investigated through in vitro studies followed by in vivo studies. In addition, studies in other species may be relevant for studies of pharmacodynamic drug-drug interactions. The results of interaction studies are used to predict a number of other interactions based on the mechanism involved. Treatment recommendations are developed based on the clinical relevance of the interactions and the possibility to make dose adjustments or treatment monitoring. This document aims as providing recommendations on all these issues. General recommendations are also provided for herbal medicinal products.

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