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In Vitro Aspects of ICH M12, Industry and Technology

Download the Presentations from the 2023 Advanced In Vitro ADME Strategies: ICH Guidelines & Novel Methodologies Symposium.

On June 9, 2023, BioIVT hosted a symposium in Denmark featuring an array of BioIVT and industry experts discussing important topics relevant to ADME/Tox research. If you were unable to attend, a selection of the presentations is now available to download, including:

In Vitro Aspects of ICH M12, Industry and Technology
Speaker: Brian Ogilvie, PhD, Vice President of Scientific Consulting, BioIVT

Abstract: 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.

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