New ICH M12 Guidelines on Drug Interactions Studies | Dr. Noémi Szili
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In June 2022, the ICH released their M12 harmonized draft guideline on Drug Interaction Studies. The ICH, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, aims to harmonize guidelines released by multiple regulatory agencies for the same purpose in order to create a single reference document that can be applied across borders. The ICH M12 will ultimately become the standard guidance for Sponsors developing compounds from pre-clinical stage through to final submission for registration. The guideline covers both in vitro and clinical drug metabolizing enzyme- and transporter-mediated drug-drug interactions by providing recommendations to support investigations and data interpretation. In this webinar, we are going to walk through the main elements of an in vitro DDI investigation study with a focus on changes in this new guidance compared to those previously published by FDA, EMA, and PMDA. The list of drug metabolizing enzyme and transporter interactions assessments will be discussed, including considerations for selecting assay systems and conditions, and data interpretation guidelines. As currently the ICH M12 is a draft guidance released for public feedback and commentary, we also aim to address some of the recommendations based on our experience as a CRO and share our initial thoughts.
This webinar is sponsored by SOLVO Biotechnology