Highlights of the In Vitro Sections of the Draft ICH Drug Interaction Studies M12 Guideline and Comparison with Current Guidance

In June 2022, the ICH released the first draft of its harmonized global Drug Interaction Studies Guideline (M12). The guideline is the result of several meetings of the Expert Working Group since 2018 with the goal of harmonizing member regulatory agencies’ guidelines to create a single guideline that will be used across all member countries. After a review period, the guideline will be adopted in early 2024.

 

Hear expert Dr. Brian Ogilvie discuss the differences between current in vitro drug-drug interaction guidance from the relevant US FDA, EMA and PMDA guidance documents, and how to plan drug development strategies to meet the ICH M12 guideline.

 

Learning Objectives