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Virtual | Virtual

Event Title
ICH M12 Drug-Drug Interaction Studies Final Guidance
October 9, 2024

Date:
October 9, 2024
Time:
1:00 p.m. - 3:00 p.m. ET

Topics & PresentationsSpeakers
ICH M12 Drug-Drug Interaction Studies Final Guidance 
ICH M12 Drug Interaction Studies Final GuidanceHelen Heymann, MMSc, PMP, CPH
Regulatory Health Project Manager
Executive Program and Project Management Staff
Office of Clinical Pharmacology (OCP)
Office of Translational Sciences (OTS) | CDER
ICH M12 Drug Interaction Final Guidance – In Vitro DDI AssessmentsXinning Yang, Ph.D.
Policy Lead
Guidance & Policy Team
OCP | OTS | CDER
Q&A Session 1Helen Heymann and Xinning Yang
ICH M12 Drug Interaction Final Guidance – Clinical DDI AssessmentsKellie Reynolds, Pharm.D.
Director
Division of Infectious Disease Pharmacology (DIDP)
OCP | OTS | CDER
Q&A Session 2

Helen Heymann, Xinning Yang, Kellie Reynolds

And

Rajanikanth Madabushi, Ph.D.
Associate Director
Guidance & Policy Team
OCP | OTS | CDER

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ABOUT THIS EVENT (Hosted by CDER SBIA)

This webinar will discuss 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 guidance describes a systemic approach to evaluation of the drug interaction potential of investigational drugs during drug development and regulatory review.

The discussion will include content related to the full scope of the guidance: in vitro evaluations, clinical studies, predictive modeling, study interpretation, risk assessment, and risk management. The subject matter experts will communicate how the various components of a drug interaction program fit together to inform safe and effective use of drugs in individuals who take multiple drugs.

INTENDED AUDIENCE

  • Scientists in pharmaceutical companies, contract research organizations, and consultant firms who work on drug metabolism, pharmacokinetics, and clinical pharmacology
  • Regulatory reviewers and policy makers working in the above areas
  • Academic researchers in fields investigating drugs interactions
  • Healthcare providers prescribing drugs to patients or consulted by patients

TOPICS

  • In vitro and clinical assessment of DDIs mediated by:
    • CYP and UGT enzymes
    • Drug transporters
  • Applications of modeling approaches and the utility of endogenous biomarkers
  • Data interpretation
  • Risk assessment and risk management

OBJECTIVES

  • Recognize the important role of in vitro DDI evaluations and how they inform clinical DDI assessment
  • Describe the need for, timing of, and study design of clinical DDI studies
  • Explain in vitro and clinical DDI study findings and modeling predictions, and translation of those results into DDI management strategies to mitigate DDI risk
  • Identify the differences between the ICH M12 DDI guidance and the previous FDA In Vitro and Clinical DDI guidances

FDA RESOURCES

 

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