title: Model-based clinical drug development in the past, present and future: a commentary.
abstract: 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.
authors: Model Based Drug Development, Janssen Research & Development, LLC of Johnson & Johnson, Raritan, NJ, 08869, USA.
authors: Holly
authors: H
authors: Kimko
authors: José
authors: J
authors: Pinheiro
mesh_terms: D003198:Computer Simulation; D055808:Drug Discovery / Q000639:trends*; D004345:Drug Industry / Q000639:trends*; D006801:Humans; D008954:Models, Biological
keywords: PK/PD; clinical trial simulation; model-based drug development; modelling; simulation