Article date: January 2015
By: Holly Kimko, José Pinheiro, in Volume 79, Issue 1, pages 108-116
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.
DOI: 10.1111/bcp.12341
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