2020 FDA Final Guidance, “In Vitro Drug Interaction Studies– Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions”

Scientific Resources 2020 FDA Final Guidance, “In Vitro Drug Interaction Studies– Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions”

• Published on January 1, 2020
• Regulatory Guidance
• Regulatory Documents

We are proud to have been cited in this final guidance for industry document, which was released by the FDA in January 2020. Access full PDF here:

“This final guidance is intended to help drug developers plan and evaluate studies to determine
the drug-drug interaction (DDI) potential of an investigational drug product. The final guidance
focuses on in vitro approaches to evaluate the interaction potential between investigational drugs
with cytochrome P450 enzymes (CYPs) and transporters as well as how in vitro results can
inform future clinical DDI studies. The appendices of this guidance include considerations when
choosing in vitro experimental systems, key issues regarding in vitro experimental conditions,
and more detailed explanations regarding model-based DDI prediction strategies.” – 2020 FDA

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Popular Access ADME^TM resources related to this document:

Webinar: Analysis of Updates in this Document & Comparison to the Current EMA & PMDA Guidance | Scientific Poster: Updated DDI Guidance Comparison  | Request a Gap Analysis