chapter  13
14 Pages

Metabolism and Transport Drug Interaction Database: A Web-Based Research and Analysis Tool

Houda Hachad, Isabelle Ragueneau-Majlessi, and René H. Levy Department of Pharmaceutics, University of

Washington, Seattle, Washington, U.S.A.

I. INTRODUCTION

It has become apparent that the most effective approach to decrease the interaction potential of a drug candidate is to address it during the earliest stages of drug development. Guidances were issued in 1997 and 1999 by regulatory agencies in the United States (1,2) and Europe (3), outlining the need for in vitro and in vivo studies for new chemical entities and the possibility of providing "class labeling." Recently, a Web site (4) was released by the FDA with the current agency's understanding of how to conduct drug-interaction studies and resulting labeling. Moreover, a new draft guidance, including additional discussions on emerging areas (transporters, nuclear receptors, etc.), is being finalized. For scientists in academia, regulatory agencies, and the pharmaceutical industry, building a drug interaction (DI) program requires rapid access to vast literature sets on metabolic isozymes, transporters, substrates, inducers, and inhibitors. That type of information is spread within a large body of literature that is relatively recent but expanding at a fast pace.