NDLI: Predicting Drug–Drug Interactions: An FDA Perspective

Content Provider	Springer Nature Link
Author	Zhang, Lei Zhang, Yuanchao Derek Zhao, Ping Huang, Shiew Mei
Copyright Year	2009
Abstract	Pharmacokinetic drug interactions can lead to serious adverse events, and the evaluation of a new molecular entity’s drug–drug interaction potential is an integral part of drug development and regulatory review prior to its market approval. Alteration of enzyme and/or transporter activities involved in the absorption, distribution, metabolism, or excretion of a new molecular entity by other concomitant drugs may lead to a change in exposure leading to altered response (safety or efficacy). Over the years, various in vitro methodologies have been developed to predict drug interaction potential in vivo. In vitro study has become a critical first step in the assessment of drug interactions. Well-executed in vitro studies can be used as a screening tool for the need for further in vivo assessment and can provide the basis for the design of subsequent in vivo drug interaction studies. Besides in vitro experiments, in silico modeling and simulation may also assist in the prediction of drug interactions. The recent FDA draft drug interaction guidance highlighted the in vitro models and criteria that may be used to guide further in vivo drug interaction studies and to construct informative labeling. This report summarizes critical elements in the in vitro evaluation of drug interaction potential during drug development and uses a case study to highlight the impact of in vitro information on drug labeling.
Starting Page	300
Ending Page	306
Page Count	7
File Format	PDF
ISSN	12341234
Journal	The AAPS Journal
Volume Number	11
Issue Number	2
e-ISSN	15507416
Language	English
Publisher	Springer US
Publisher Date	2009-05-06
Publisher Institution	American Association of Pharmaceutical Scientists
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	drug development drug–drug interaction new drug application prediction regulatory and guidance Pharmacy Biotechnology Biochemistry Pharmacology/Toxicology
Content Type	Text
Resource Type	Article

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