This webinar discussed the ICH M12 Drug Interaction Studies guidance which is the first globally harmonized regulatory guidance on assessments of pharmacokinetic drug interactions mediated by metabolic enzymes and drug transporters. The discussion included content related to the full scope of the guidance: in vitro evaluations, clinical studies, predictive modeling, study interpretation, risk assessment, and risk management.
Timestamps
01:00 – ICH M12 Drug Interaction Studies Final Guidance
08:58 – ICH M12 Drug Interaction Final Guidance – In Vitro DDI Assessments
40:41 – Q&A Session 1
57:51 – ICH M12 Drug Interaction Final Guidance – Clinical DDI Assessments
01:20:22 – Q&A Session 2
Speakers | Panelists:
Kellie Reynolds, Pharm.D.
Director
Division of Infectious Disease Pharmacology (DIDP)
Office of Clinical Pharmacology (OCP)
Office of Translational Sciences (OTS) | CDER
Xinning Yang, Ph.D.
Policy Lead
Guidance & Policy Team
OCP | OTS | CDER
Helen Heymann, MMSc, PMP, CPH
Regulatory Health Project Manager
Executive Program and Project Management Staff
OCP | OTS | CDER
Rajanikanth Madabushi, Ph.D.
Associate Director
Guidance & Policy Team
OCP | OTS | CDER
Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/ich-m12-drug-drug-interaction-studies-final-guidance-10092024
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