Gieschke R, Reigner B G, Steimer J L
Pharma Development, F. Hoffmann-La Roche, Basel, Switzerland.
Int J Clin Pharmacol Ther. 1997 Oct;35(10):469-74.
Computer simulations have been successfully applied in various industries (e.g. automobile, aerospace) to make product development more efficient. Just recently, it was suggested to use simulations in support of clinical drug development for predicting clinical outcomes of planned trials. The methodological basis for this approach is provided by pharmacokinetic and pharmacodynamic mathematical models together with Monte Carlo techniques. In the present paper, the basic notions of clinical trial simulation are introduced and illustrated with the example of an oral anticancer drug. It is shown that computer simulation helps to evaluate consequences of design features on safety and efficacy assessment of the drug which are not easily obtained otherwise. An overview of existing simulation resources with respect to training and software is provided.
计算机模拟已成功应用于各个行业（如汽车、航空航天），以提高产品开发效率。最近，有人建议使用模拟来支持临床药物开发，以预测计划试验的临床结果。这种方法的方法论基础是由药代动力学和药效学数学模型以及蒙特卡洛技术提供的。在本文中，介绍了临床试验模拟的基本概念，并以一种口服抗癌药物为例进行了说明。结果表明，计算机模拟有助于评估设计特征对药物安全性和有效性评估的影响，而这些影响用其他方法不易获得。本文还提供了有关培训和软件的现有模拟资源概述。
