Model-Based Drug Development: Basics and Its Application

Abstract

In drug development, the low productivity causing escalated costs has been documented for over the past decade. To overcome this significant challenge, Model-Based Drug Development (MBDD) is considered as one of the opportunities. MBDD is the drug development based on the integrated pharmaco-statistical models of drug efficacy and safety with available data and their application to inform development strategy, trial design and decision-making in the drug development. MBDD covers overall drug development stage including both pre-clinical and clinical stage and improves knowledge management and decision-making in a quantitative manner. This article introduces basics of MBDD from the theoretical and the practical point of view with some examples and shows its application for the clinical drug development of the anti-diabetes drug.