PDF(Pubmed)
Abstract：
BACKGROUND: Nowadays, the inception of computer modeling and simulation in life science is a matter of fact. This is one of the reasons why regulatory authorities are open in considering in silico trials evidence for the assessment of safeness and efficacy of medicinal products. In this context, mechanistic Agent-Based Models are increasingly used. Unfortunately, there is still a lack of consensus in the verification assessment of Agent-Based Models for regulatory approval needs. VV&UQ is an ASME standard specifically suited for the verification, validation, and uncertainty quantification of medical devices. However, it can also be adapted for the verification assessment of in silico trials for medicinal products.
RESULTS: Here, we propose a set of automatic tools for the mechanistic Agent-Based Model verification assessment. As a working example, we applied the verification framework to an Agent-Based Model in silico trial used in the COVID-19 context.
CONCLUSIONS: Using the described verification computational workflow allows researchers and practitioners to easily perform verification steps to prove Agent-Based Models robustness and correctness that provide strong evidence for further regulatory requirements.
RESULTS: Here, we propose a set of automatic tools for the mechanistic Agent-Based Model verification assessment. As a working example, we applied the verification framework to an Agent-Based Model in silico trial used in the COVID-19 context.
CONCLUSIONS: Using the described verification computational workflow allows researchers and practitioners to easily perform verification steps to prove Agent-Based Models robustness and correctness that provide strong evidence for further regulatory requirements.
摘要：
背景：如今，计算机建模和仿真在生命科学中的出现是事实。这就是监管当局开放考虑评估药品安全性和有效性的硅片试验证据的原因之一。在这种情况下，机械论的基于Agent的模型被越来越多地使用。不幸的是,对于监管批准的需求，在基于代理的模型的验证评估方面仍然缺乏共识。VV&UQ是专门用于验证的ASME标准，验证,和医疗器械的不确定性量化。然而,它也可以适用于药品的计算机模拟试验的验证评估。
结果：这里，我们提出了一套自动工具，用于机械的基于Agent的模型验证评估。作为一个工作例子，我们将验证框架应用于在COVID-19背景下使用的基于代理的模型模拟试验.
结论：使用所描述的验证计算工作流程，研究人员和从业人员可以轻松地执行验证步骤，以证明基于代理的模型的稳健性和正确性，为进一步的监管要求提供有力的证据。
结果：这里，我们提出了一套自动工具，用于机械的基于Agent的模型验证评估。作为一个工作例子，我们将验证框架应用于在COVID-19背景下使用的基于代理的模型模拟试验.
结论：使用所描述的验证计算工作流程，研究人员和从业人员可以轻松地执行验证步骤，以证明基于代理的模型的稳健性和正确性，为进一步的监管要求提供有力的证据。
