Model-based clinical drug development in the past,present and future: a commentary |
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Authors: | Holly Kimko José Pinheiro |
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Affiliation: | Model Based Drug Development, Janssen Research & Development, LLC of Johnson & Johnson, Raritan, NJ, 08869, USA |
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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. |
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Keywords: | clinical trial simulation model-based drug development modelling PK/PD simulation |
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