Journal
JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 106, Issue 9, Pages 2209-2213Publisher
WILEY
DOI: 10.1016/j.xphs.2017.04.045
Keywords
drug interaction; cytochrome P450s; membrane transport/transporters; regulatory; guidance/guideline
Funding
- U.S. FDA's Medical Countermeasures initiative
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Evaluation of drug-drug interaction (DDI) risk is vital to establish benefit-risk profiles of investigational new drugs during drug development. In vitro experiments are routinely conducted as an important first step to assess metabolism-and transporter-mediated DDI potential of investigational new drugs. Results from these experiments are interpreted, often with the aid of in vitro-in vivo extrapolation methods, to determine whether and how DDI should be evaluated clinically to provide the basis for proper DDI management strategies, including dosing recommendations, alternative therapies, or contraindications under various DDI scenarios and in different patient population. This article provides an overview of currently available in vitro experimental systems and basic in vitroein vivo extrapolation methodologies for metabolism-and transporter-mediated DDIs. Published by Elsevier Inc. on behalf of the American Pharmacists Association.
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