Kimko Holly, Pinheiro José
Model Based Drug Development, Janssen Research & Development, LLC of Johnson & Johnson, Raritan, NJ, 08869, USA.
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.
临床药物开发仍然是一项主要基于经验且成本高昂的事业，在这个过程中，决策往往基于对风险的定性评估，而没有充分利用在整个开发项目中收集到的所有相关数据。监管机构、学术界和制药公司都提出了基于模型的药物开发（MBDD），作为一种通过量化风险和整合不同时期不同来源的信息来实现药物研究现代化的范例。我们在此介绍MBDD在临床药物开发中的应用历史、当前面临的挑战以及其在制药行业应用的更多机遇。
