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Topic
Pharmaron's DMPK Webinar Series
Date & Time
Selected Sessions:
Apr 10, 2025 09:00 AM
Description
April DMPK Webinar: What’s New with the ICH M12 Guidance on Drug-Drug Interactions?
This webinar will discuss changes in regulatory guidance about predicting the risk of drug-drug interactions (DDIs), as codified in ICH M12 compared with previous FDA and EMA guidance.
Agenda:
- The regulatory landscape of in-vitro DDI assays
- New aspects of testing requirements according to ICH M12
- Study designs and workflows
- Clinical DDI risk prediction