University of Tennessee Health Science Center, College of Pharmacy, Department of Pharmaceutical Sciences, 874 Union Avenue, Suite 5p, Memphis, TN 38163, USA +1 901 448 1206 ; +1 901 448 6940 ;
Expert Opin Drug Discov. 2010 Apr;5(4):311-21. doi: 10.1517/17460441003713470.
Current drug discovery and development programs are under growing scrutiny for low productivity and escalating costs. Model-based drug development (MBDD) has been recognized as a promising tool to address some of the related challenges.
This review introduces the concept of MBDD and the associated quantitative pharmacology-based iterative 'learn and confirm' paradigm in the drug discovery and development process to provide concise information for rational decision making. It summarizes the evolving role of MBDD in drug development programs and outlines the full armamentarium of modeling and simulation approaches utilized to facilitate its application.
Different aspects and applications of MBDD are introduced to the reader and illustrated in prime examples. The reader is provided with an understanding of potential applications of MBDD in drug development as well as the associated limitations and challenges in its implementation.
MBDD is a tool that is increasingly used throughout the drug discovery and development continuum to support fast and rationale decision making and has thereby the potential to accelerate and increase the cost-effectiveness of the drug development process.
当前的药物发现和开发计划正受到越来越多的关注,因为其生产率低和成本不断上升。基于模型的药物开发(MBDD)已被认为是解决相关挑战的一种有前途的工具。
本篇综述介绍了 MBDD 的概念,以及在药物发现和开发过程中相关的基于定量药理学的迭代“学习和确认”范例,为合理决策提供简明信息。它总结了 MBDD 在药物开发计划中的不断发展的作用,并概述了用于促进其应用的建模和模拟方法的全套工具。
向读者介绍了 MBDD 的不同方面和应用,并以主要示例进行了说明。读者将了解 MBDD 在药物开发中的潜在应用,以及在实施过程中存在的相关局限性和挑战。
MBDD 是一种工具,在药物发现和开发的连续体中被越来越多地使用,以支持快速和合理的决策,并因此有可能加速和提高药物开发过程的成本效益。