In clinical practice, patients are often prescribed more than one drug which can result in a drug-drug interaction (DDI).
The European Medicines Agency (EMA) has published the “Draft International Council for Harmonisation (ICH) Guideline M12 on drug interaction studies” for public consultation. This important guideline provides recommendations to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical DDI studies during the development of a therapeutic product.
Guidance is provided on how to investigate interactions mediated by inhibition or induction of enzymes or transporters, both in vitro and in vivo, and on how to translate the results to appropriate treatment recommendations. Moreover, the guideline includes recommendations on how to address metabolite-mediated interactions. The use of model-based data evaluation and DDI predictions are also covered.
A consistent approach will reduce uncertainty for pharmaceutical industry to meet the requirements of multiple regulatory agencies and lead to more efficient utilization of resources.
Comments should be provided to [email protected] by 21 November 2022.
More details about the guidelines and the template needed to provide feedback can be accessed here.