Charles River Laboratories International Inc.
09/18/2024 | News release | Distributed by Public on 09/19/2024 07:27
Discussing the Recent Updates to ICH M12
The recently released update to the International Council of Harmonisation (ICH) M12 guidelines provides a definitive version of their guidance for Drug-Drug Interaction (DDI) studies. These new, final guidelines are intended to replace regional and local guidelines to become the global standard for addressing DDI. The document offers updated recommendations for your in vitro and clinical study design and data interpretation.
Our recent webinar on these updates focused on how the ICH M12 affects your in vitro studies, discussing:
- Key changes that have been made in 2024's final updates
- The main differences compared to 2020 FDA DDI guidelines
- Major suggestions which were adopted from 2022 public consultation of the previous draft
- How the guidelines approach new modalities
- The recommended timing for generating the required in vitro DDI data
The presentation also included a panel discussion with the presenters to address first impressions and discuss application considerations and future perspectives.