Use of Computer and In Vitro Modeling Techniques during the Development of Pediatric Circulatory Support Devices
Use of Computer and In Vitro Modeling Techniques during the Development of Pediatric Circulatory Support Devices
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DOI：
10.1097/mat.0b013e318198dd88
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发表时间：
2009-01-01
期刊：
影响因子：
4.2
通讯作者：
Pantalos, George
中科院分区：
文献类型：
--
作者：
Pantalos, George
儿科机械循环装置目前正在由几个项目开发。除了要考虑的工程和测试挑战外，还需要考虑监管程序，该程序将用于审查向食品和药物管理局（FDA）提交的申请，以启动这些设备的临床试验。本文考虑适当使用计算机和体外建模数据作为儿科循环支持装置的FDA研究器械豁免提交的一部分。首先，讨论了可能使用的建模技术的类型和价值。如何独特的生理，血流需求，和解剖儿科患者可能会影响建模的努力，然后回顾。建模假设、论证和验证是作为FDA提交的一部分提交的建模数据的关键方面。最后，对向FDA提交临床试验时适当使用建模数据提出了关键建议。
Pediatric mechanical circulatory devices are currently being developed by several programs. Along with the engineering and testing challenges to be considered is the regulatory process which will be used to review applications to the Food and Drug Administration (FDA) to initiate clinical trials with these devices. This paper considers the appropriate use of computer and in vitro modeling data as a part of an FDA Investigational Device Exemption submission for a pediatric circulatory support device. Initially, the types and value of modeling techniques that may be used are discussed. How the unique physiology, flow requirements, and anatomy of pediatric patients may affect modeling efforts is then reviewed. Modeling assumptions, justification, and validation are key aspects of modeling data to be submitted as a part of an FDA submission. Finally, key recommendations are made for the appropriate use of modeling data for an FDA clinical trial submission.