- April 24, 2020
1:30 PM - 3:00 PM ET
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
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.
- 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
- Healthcare providers prescribing drugs to patients
Dr. Kellie Reynolds, Pharm. D.
Division of Infectious Disease Pharmacology | Office of Clinical Pharmacology | CDER | FDA
Dr. Xinning Yang, Ph.D.
Guidance & Policy Team | Office of Clinical Pharmacology | CDER | FDA