Predicting human hepatic clearance from<i>in vitro</i>drug metabolism and transport data: a scientific and pharmaceutical perspective for assessing drug–drug interactions

Abstract

The presented approach serves as a basis for accurate compound categorization within the Biopharmaceutics Drug Disposition Classification System (BDDCS) and was applied to anticipate metabolism- and transporter-based drug-drug interactions using different static prediction methods. A decision tree proposal is provided and helps to guide clinical studies on active processes influencing hepatic elimination. All recommendations in this paper are generally intended to support early pre-clinical and clinical drug development and the filing of a new drug application.