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GUIDANCE DOCUMENT

In Vitro Metabolism- and Transporter- Mediated Drug-Drug Interaction Studies Guidance for Industry October 2017

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.