Gobburu J V, Marroum P J
Division of Pharmacometrics, United States Food and Drug Administration, Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Rockville, Maryland 20852, USA.
Clin Pharmacokinet. 2001;40(12):883-92. doi: 10.2165/00003088-200140120-00001.
Modelling and simulation (M&S) play an important role in regulatory decision-making that affects both the public and industry. Technological advances in various fields related to drug development call for more focus on ways to optimise current drug development practices. Recognition of the potential of M&S by regulatory agencies inevitably has a substantial impact on drug development. The objective of the current review is to present the various regulatory initiatives for application of M&S to clinical drug development. The relevant parts of the various recommendations issued by the US Food and Drug Administration (FDA), via guidance documents and advisory committee meeting proceedings, are highlighted. Application of M&S to a variety of activities, such as integrating pharmacokinetic-pharmacodynamic knowledge across a new drug application and designing efficient trials, is discussed. Some of the challenges that pharmaceutical institutions currently face when implementing M&S projects, such as team structure, communication with regulators, training and time constraints, are also presented, and solutions are proposed.
建模与仿真（M&S）在影响公众和行业的监管决策中发挥着重要作用。药物研发相关各个领域的技术进步要求更加关注优化当前药物研发实践的方法。监管机构对建模与仿真潜力的认可必然会对药物研发产生重大影响。本综述的目的是介绍将建模与仿真应用于临床药物研发的各种监管举措。重点突出了美国食品药品监督管理局（FDA）通过指导文件和咨询委员会会议记录发布的各项建议的相关部分。讨论了建模与仿真在各种活动中的应用，例如在新药申请中整合药代动力学-药效学知识以及设计高效试验。还介绍了制药机构目前在实施建模与仿真项目时面临的一些挑战，如团队结构、与监管机构的沟通、培训和时间限制，并提出了解决方案。
