Drug-drug interaction studies: regulatory guidance and an industry perspective.

ABSTRACT: Recently, the US Food and Drug Administration and European Medicines Agency have issued new guidance for industry on drug interaction studies, which outline comprehensive recommendations on a broad range of in vitro and in vivo studies to evaluate drug-drug interaction (DDI) potential. This paper aims to provide an overview of these new recommendations and an in-depth scientifically based perspective on issues surrounding some of the recommended approaches in emerging areas, particularly, transporters and complex DDIs. We present a number of theoretical considerations and several case examples to demonstrate complexities in applying (1) the proposed transporter decision trees and associated criteria for studying a broad spectrum of transporters to derive actionable information and (2) the

SUBMITTER: Prueksaritanont T 

PROVIDER: S-EPMC3691435 | biostudies-literature | 2013 Jul

REPOSITORIES: biostudies-literature