从全球药品监管科学视角看计算机建模与仿真新方法的发展现状及趋势  

Development and Trends of New Methods for Computer Modeling and Simulation in Global Drug Regulatory Science

作　　者：赵宇 张静 张春明[3] 张伟 ZHAO Yu;ZHANG Jing;ZHANG Chun-ming;ZHANG Wei(Turing Darwin Laboratory;Western Institute of Computing Technology;Institute of Computing Technology,Chinese Academy of Sciences;China Society for Drug Regulation)

机构地区：[1]图灵-达尔文实验室 [2]中科计算技术西部研究院 [3]中国科学院计算技术研究所 [4]中国药品监督管理研究会

出　　处：《中国食品药品监管》2023年第7期6-15,共10页China Food & Drug Administration Magazine

摘　　要：计算机建模与仿真在提升药物研发效能、创新监管科学发展中具有重要意义。本文首先从战略视角分析了计算机建模与仿真在全球主要国家和地区的监管科学发展中的战略地位,剖析了其在药物研发与监管科学发展中的战略意义。其次,本文以“科学界针对各种应用场景开发有价值的建模仿真科学工具,监管机构将有价值的科学工具转变为有价值的监管科学工具,并形成更多数字化证据的运行机制”为牵引,对近期全球的创新探索进行了分类总结。最后,为了推动我国计算机建模与仿真在监管科学、医药研发中深化应用,提出了面向未来的行动建议,即加快弥合跨学科思维方式差异,打造虚拟临床试验样板,建立中国的应用场景清单,促进有价值的科学工具转变为有价值的监管科学工具。Computer modeling and simulation is of great significance in improving the efficiency of drug research and development and fostering innovation in regulatory science.This paper first analyzes the strategic position of computer modeling and simulation in the development of regulatory science across major countries and regions globally from a strategic perspective,shedding light on the strategic significance in drug research and development and regulatory science.Secondly,the paper classifies and summarizes recent global innovative explorations using computer modeling and simulation.The classification and summary are based on the concept of"the scientific community developing valuable modeling and simulation tools for various application scenarios,while regulatory agencies turn those tools into valuable regulatory scientific resources,thus establishing an operational mechanism for digital evidence".Finally,in order to promote the wider application of computer modeling and simulation in China and guide the rapid development of pharmaceutical research and development,this paper puts forward future-oriented action suggestions.These include expediting the bridging of interdisciplinary thinking gaps,building a prototype of virtual clinical trials,establishing a list of demand scenarios specific to China,and facilitating the transformation of valuable scientific tools into valuable regulatory scientific resources.

关 键 词：监管科学 计算机建模与仿真 虚拟临床试验 

分 类 号：R95[医药卫生—药学]