Guidance for Industry: Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro

摘要

This Food and Drug Administration (FDA) guidance to industry provides suggestions on current approaches to studies in vitro of drug metabolism and interactions. The guidance is intended to encourage routine, thorough evaluation of metabolism and interactions in vitro whenever feasible and appropriate. As is the case for all FDA guidance documents, suggestions are not requirements, but are offered for consideration by drug development scientists as a means to address potentially important safety concerns. FDA recognizes that the importance of any approach will vary depending on the drug in development and its intended clinical use. The FDA also recognizes that clinical observations can address some of the same issues identified in this document as being susceptible to in vitro study. The suggested approaches delineated in this document, however, are efficient and inexpensive considering the breadth of information they can provide, and often can reduce or eliminate the need for further clinical investigations. This particular guidance is directed toward a broad class of drugs: molecules with a molecular weight below 10 kiloDaltons.