Model-based clinical drug development in the past, present and future: a commentary

Br J Clin Pharmacol. 2015 Jan;79(1):108-16. doi: 10.1111/bcp.12341.


Clinical drug development remains a mostly empirical, costly enterprise, in which decision-making is often based on qualitative assessment of risk, without properly leveraging all the relevant data collected throughout the development programme. Model-based drug development (MBDD) has been proposed by regulatory agencies, academia and pharmaceutical companies as a paradigm to modernize drug research through the quantification of risk and combination of information from different sources across time. We present here a historical account of the use of MBDD in clinical drug development, the current challenges and further opportunities for its application in the pharmaceutical industry.

Keywords: PK/PD; clinical trial simulation; model-based drug development; modelling; simulation.

Publication types

  • Review

MeSH terms

  • Computer Simulation*
  • Drug Discovery / trends*
  • Drug Industry / trends*
  • Humans
  • Models, Biological*