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ABOUT

This webinar will discuss two FDA final guidances that provide a systemic approach to the evaluate the drug-drug interaction (DDI) potential of investigational drugs and describe how the approach can be implemented. The two final guidances are:

• In Vitro Drug Interaction Studies - Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions
• Clinical Drug Interaction Studies - Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions

LEARNING OBJECTIVES

At the end of this webinar, participants should be able to:

• Understand the important role of in vitro DDI evaluations and how they inform clinical DDI assessment.
• Describe the need for, timing of, and multiple design features of clinical DDI studies.
• Interpret in vitro and clinical DDI study findings and translation of those findings into DDI management strategies that health care providers communicate to patients.

INTENDED AUDIENCE

• Scientists in pharmaceutical companies and contract research organizations working on drug metabolism, pharmacokinetics, and clinical pharmacology
• Regulatory reviewers and policy makers working in those areas
• Academic researchers in those fields
• Pharmacists
• Healthcare providers prescribing drugs to patients

FDA SPEAKERS

Dr. Kellie Reynolds, Pharm. D.
Director
Division of Infectious Disease Pharmacology | Office of Clinical Pharmacology | CDER | FDA

Dr. Xinning Yang, Ph.D.
Policy Lead
Guidance & Policy Team | Office of Clinical Pharmacology | CDER | FDA

RESOURCES

1. FDA guidance for industry: In Vitro Drug Interaction Studies - Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions,
2. FDA guidance for industry: Clinical Drug Interaction Studies - Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions,