InSilicoTrials Technologies S.P.A, Riva Grumula 2, 34123, Trieste, Italy.
InSilicoTrials Technologies B.V., Bruistensingel 130, 5232 AC, 's Hertogenbosch, The Netherlands.
Ann Biomed Eng. 2023 Jan;51(1):125-136. doi: 10.1007/s10439-022-03052-6. Epub 2022 Sep 8.
The use of in silico trials is expected to play an increasingly important role in the development and regulatory evaluation of new medical products. Among the advantages that in silico approaches offer, is that they permit testing of drug candidates and new medical devices using virtual patients or computational emulations of preclinical experiments, allowing to refine, reduce or even replace time-consuming and costly benchtop/in vitro/ex vivo experiments as well as the involvement of animals and humans in in vivo studies. To facilitate and widen the adoption of in silico trials, InSilicoTrials Technologies has developed a cloud-based platform, hosting healthcare simulation tools for different bench, preclinical and clinical evaluations, and for diverse disease areas. This paper discusses four use cases of in silico trials performed using the InSilicoTrials.com platform. The first application illustrates how in silico approaches can improve the early preclinical assessment of drug-induced cardiotoxicity risks. The second use case is a virtual reproduction of a bench test for the safety assessment of transcatheter heart valve substitutes. The third and fourth use cases are examples of virtual patients generation to evaluate treatment effects in multiple sclerosis and prostate cancer patients, respectively.
预计在新药开发和监管评估中，计算机模拟试验将发挥越来越重要的作用。计算机模拟方法具有许多优势，例如可以使用虚拟患者或临床前实验的计算模拟来测试候选药物和新型医疗器械，从而可以改进、减少甚至取代耗时且昂贵的台式/体外/离体实验，以及减少动物和人体在体内研究中的应用。为了促进和推广计算机模拟试验，InsilicoTrials Technologies 开发了一个基于云的平台，其中托管了用于不同台式、临床前和临床评估以及不同疾病领域的医疗保健模拟工具。本文讨论了使用 InsilicoTrials.com 平台进行的四个计算机模拟试验用例。第一个应用说明了计算机模拟方法如何改善药物诱导的心脏毒性风险的早期临床前评估。第二个用例是经导管心脏瓣膜替代品安全性评估的台式测试的虚拟再现。第三个和第四个用例分别是生成虚拟患者以评估多发性硬化症和前列腺癌患者的治疗效果的示例。
