Evolving role of modeling and simulation in drug development.
Evolving role of modeling and simulation in drug development.
复制标题
DOI：
10.12793/tcp.2019.27.1.19
复制
发表时间：
2019-03-01
影响因子：
0.9
通讯作者：
Lim, Hyeong-Seok
中科院分区：
文献类型：
--
作者：
Lim, Hyeong-Seok
药代动力学-药效学模型是以数学公式的形式定量描述药物相关结果的一种语言。各种结果如果能用数字表示，就可以进行建模分析。经验模型在药物开发和研究中得到了广泛而成功的应用。然而，竞争更激烈的药物开发环境需要在药物开发的早期阶段建立更准确和更具预测性的模型。因此，PK-PD建模的对象已经从临床数据扩展到发现阶段的临床前和体外数据。更多的机制和预测模型，如基于生理的药代动力学和基于定量系统的药理学模型，正在越来越多地使用，因为越来越需要在早期更准确地表征药物。本教程简要介绍了PK-PD建模和仿真的基本概念，并描述了近年来PK-PD模型在新药开发过程中应用的角色变化。
Pharmacokinetic-pharmacodynamic model is a kind of language that quantitatively describes the drug-related outcomes in the form of mathematical formula. Various outcomes can be subjected to modeling analysis if they can be expressed in numbers. Empirical models have been widely and successfully applied in drug development and research. However, a more competitive drug development environment requires more accurate and predictive models in the early stages of drug development. Accordingly, the subjects of PK-PD modeling have been extended from clinical data to preclinical and in vitro data in the discovery stage. More mechanistic and predictive models, such as physiologically based pharmacokinetic and quantitative system-based pharmacology models, are being increasingly used owing to the growing need to characterize drugs more accurately at the earliest. This tutorial briefly introduces the essential concepts of PK-PD modeling and simulation and describes the recent changing roles of PK-PD model for application in novel drug development process.