The current role of model-based drug development.

IMPORTANCE OF THE FIELD: Current drug discovery and development programs are under growing scrutiny for low productivity and escalating costs. Model-based drug development (MBDD) has been recognized as a promising tool to address some of the related challenges. AREAS COVERED IN THIS REVIEW: This review introduces the concept of MBDD and the associated quantitative pharmacology-based iterative 'learn and confirm' paradigm in the drug discovery and development process to provide concise information for rational decision making. It summarizes the evolving role of MBDD in drug development programs and outlines the full armamentarium of modeling and simulation approaches utilized to facilitate its application. WHAT THE READER WILL GAIN: Different aspects and applications of MBDD are introduced to the reader and illustrated in prime examples. The reader is provided with an understanding of potential applications of MBDD in drug development as well as the associated limitations and challenges in its implementation. TAKE HOME MESSAGE: MBDD is a tool that is increasingly used throughout the drug discovery and development continuum to support fast and rationale decision making and has thereby the potential to accelerate and increase the cost-effectiveness of the drug development process.