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Model‐based clinical drug development in the past, present and future: a commentary
Author(s) -
Kimko Holly,
Pinheiro José
Publication year - 2015
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/bcp.12341
Subject(s) - drug development , pharmaceutical industry , drug , risk analysis (engineering) , medicine , data science , business , management science , computer science , process management , pharmacology , engineering
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.