Guidance on Drug Interaction Studies —From the Standpoint of Clinical Field and Science—

Abstract

It is important for the health care professionals, such as physicians and pharmacists, to get the sufficient drug interaction data concerning the prescribed drugs. The mechanisms of the interactions were categorized generally as being pharmacokinetic or pharmacodynamic types. The guidance on drug interaction studies (draft), presented in April 2000, mainly refers to pharmacokinetic interaction rather than pharmacodynamic interaction. On the other hand, although the most basic tool for getting information on drugs is package inserts, many health care professionals has lack information on drug interaction from it. This paper discussed the guidance on drug interaction studies from the standpoint of clinical field and science, and emphasized the importance of PK/PD analysis to predict serious drug interaction for rational clinical pharmacotherapy.