Highlights from the Final ICH M12 Drug Interaction Studies Guideline

Highlights From the Final ICH M12 Guideline “Drug Interaction Studies” — What’s changed and considerations for your IND programs
Presenter: Brian Ogilvie, PhD, VP of Scientific Consulting at BioIVT

The ICH M12 Guideline was finalized on May 21st, 2024, after extensive review of industry and other comments. The Guideline is the culmination of the extensive work by the Expert Working Group. The Expert Working Group was formed in 2018 and is a committee of experts charged with harmonizing member regulatory agencies’ guidelines to create a single guideline that will be used across all member countries. The new Guideline replaces the corresponding drug interaction guidance documents from the US FDA, EMA, and PMDA, among others.

This presentation offers perspectives on changes from the draft ICH M12 and differences between in vitro drug-drug interaction guidance from the relevant US FDA, EMA and PMDA guidance documents, as well as how to plan drug development strategies to meet the expectations of the final ICH M12 Guideline.

Key concepts discussed in this webinar include:
An overview of changes to the in vitro sections from the draft to the final ICH M12 Guideline
A comparison of the in vitro sections of the final ICH M12 Guideline with previous guidance from FDA, EMA and PMDA
A comparison of the equations and cutoff values highlighting changes from the draft version
A comparison of in vitro experimental details highlighting changes from the draft version
Impacts of finalization of the ICH M12 on in vitro DDI study design and interpretation

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About the Presenter
Dr. Brian Ogilvie is the VP of Scientific Consulting at BioIVT, where he leads a team that advises clients on in vitro drug-drug interaction studies and program strategy. He received a Ph.D. in toxicology from the University of Kansas Medical Center. He has published various research articles and book chapters and has been an invited speaker at numerous drug development conferences.