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. See section VIII for a list of terms used in this guidance and their definitions.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
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All comments should be identified with the title of the guidance.