ICH M12 Drug-Drug Interaction Studies Final Guidance

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

-----------------------

FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

Phone - [phone] I [phone]