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首页> 外文会议>American Society for Engineering Management(ASEM) National Conference; 20041020-23; Alexandria,VA(US) >USING SIMULATION TO UNDERSTAND THE EFFECT OF UNCERTAINTIES IN THE DRUG DEVELOPMENT PROCESS
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USING SIMULATION TO UNDERSTAND THE EFFECT OF UNCERTAINTIES IN THE DRUG DEVELOPMENT PROCESS

机译：使用模拟了解药物开发过程中不确定性的影响

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摘要

The purpose of this paper is to discuss the uncertainties introduced during the process of drug development, define quantified discrete event simulation and their cumulative effect upon R&D productivity after the process of drug development was modeled. The four key input variables modeled were process time for preclinical and clinical trials, attrition rate as the drug attempts to pass scientific and medical hurdles, human resources required represented by full time equivalents (FTEs) and the direct cost for each phase of development. Cumulative and dependent variability is not easily captured in traditional spreadsheet models, especially when modeling processes whose states change at random points in time. We use discrete event simulation in order to handle random times, resources, and dependencies. This paper should increase the visibility of the complexity and variability of the ethical drug development process, and the model described should enhance long-term system control, productivity, stability, and decision support.
机译：本文的目的是讨论在药物开发过程中引入的不确定性，定义量化的离散事件模拟及其对药物开发过程建模后对研发生产率的累积影响。建模的四个关键输入变量是临床前和临床试验的处理时间，药物尝试通过科学和医学障碍时的人员流失率，以全职当量（FTE）表示的所需人力资源以及每个开发阶段的直接成本。在传统的电子表格模型中，尤其是在建模过程的状态在随机时间点改​​变的情况下，累积和因变量是不容易捕获的。为了处理随机时间，资源和依赖关系，我们使用离散事件模拟。本文应提高对道德药物开发过程的复杂性和可变性的可视性，并且所描述的模型应增强长期系统控制，生产率，稳定性和决策支持。

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