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2017 FDA Draft Guidance, “In Vitro Metabolism- and Transporter- Mediated Drug-Drug Interaction Studies”

  • Published on October 25, 2017
  • Regulatory Guidance
  • Publications
  • Regulatory Documents

Published by the FDA in 2017, this is the Draft guidance for industry, “In Vitro Metabolism- and Transporter- Mediated Drug-Drug Interaction Studies”

“This guidance is intended to help drug developers plan and evaluate studies to determine the drug-drug interaction (DDI) potential of an investigational drug product.
It focuses on in vitro experimental approaches to evaluate the interaction potential between investigational drugs that involves metabolizing enzymes and/or transporters. This guidance also discusses 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.”

 

You might also be interested in our webinar “Essential Considerations on the New FDA In Vitro DDI Guidance (the What, the Why, and the Wow).”

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