Presentation
In June 2022, the ICH released the draft of its harmonized Drug Interaction Studies Guideline (M12). The guideline resulted from several meetings of the Expert Working Group since 2018 with the goal of harmonizing member regulatory agencies’ guidelines into one that will be used across all member countries. After review, the guideline will be adopted in 2024. This presentation will describe differences between current in vitro drug-drug interaction guidance from the relevant US FDA, EMA and PMDA guidance documents, and how to plan on meeting the ICH M12 guideline.
Title: Highlights of the In Vitro Sections of the Draft ICH Drug Interaction Studies M12 Guideline and Comparison with Current Guidance
Date: Wednesday, September 13
Time: 7:15 - 8:15 AM
This session is an industry-sponsored symposium. Although not an official part of the 25th North American ISSX Meeting, this program has been reviewed and its presentation permitted by the meeting organizers.