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Refinement, Reduction, and Replacement (3R) Strategies in Preclinical Testing of Medical Devices

机译：医疗器械临床前测试中的改进，减少和更换（3R）策略

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摘要

The U.S. Food and Drug Administration Center for Devices and Radiological Health (FDA/CDRH) has recently published several in vivo test guidance documents that mention refinements, reductions, or replacement animal testing strategies to facilitate the leveraging of data from large animal safety tests for conventional rodent testing. In response to the recently enacted Food and Drug Administration Safety and Innovation Act Section 907, which facilitates expedited access to novel therapies commonly described as Breakthrough Therapy Designation, FDA/CDRH has discussed efficient regulatory strategies for first-in-human investigation, including early feasibility study guidance. Large gains in humane care and translational research could also be attained by examples in FDA’s Guidance for the Use of International Organization for Standardization 10993-1, which states that large animal safety studies may be considered as replacement rodent tests if the scientific principles, methods, and end points (SPME) are considered and applied. This article discusses SPME for the replacement of conventional rodent testing by the inclusion and integration of clinical, diagnostic, and pathologic data obtained from well-designed large animal studies. The recommendations include consideration for study designs that utilize methods for an overall more comprehensive interrogation of animal systems.
机译：美国食品和药品管理局（FDA / CDRH）最近发表了几个体内试验指导文件，提到了改进，减少或更换动物测试策略，以便于杠杆从常规的大型动物安全测试中的数据啮齿动物测试。为了回应最近颁布的食品和药物管理局安全和创新法案第907款，这有助于加快进入常见于突破治疗指定的新型疗法，FDA / CDRH讨论了先进性调查的有效监管策略，包括早期可行性研究指导。 FDA中的人道护理和翻译研究中的大量收益也可以通过FDA使用国际标准化组织的指导，这使得大型动物安全性研究可能被视为替代啮齿动物试验，如果科学原则，方法，和终点（SPME）进行考虑和应用。本文讨论了SPME通过纳入和整合从精心设计的大型动物研究中获得的临床，诊断和病理数据来更换传统啮齿动物测试。该建议包括考虑研究设计，该设计利用了对动物系统更全面的询问的方法。

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