Article summary
The International Council for Harmonisation (ICH) has adopted its M12 guidance, which promotes a harmonised approach in conducting and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction (DDI) studies during the development of an investigational therapeutic drug. Step 4 means the document is ready for regulators to adopt in their jurisdictions. The ICH M12 DDI guidance was released for public consultation in May 2022 and received a large response from pharma wanting more clarity on the timing of DDI studies as well as the scope of these studies. The guideline 'provides general recommendations for DDI evaluation due to the many possible combinations of drugs, patient populations and therapeutic contexts, but also contains specific recommendations in well-established areas.' ICH also released a supporting question and answer document to clarify points raised about drug interaction assessments as well as a training presentation to help with the guide’s implementation. Currently, the jurisdictional variation in conducting these studies...
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