Hampshire Victoria A, Gilbert Samuel H
1 Capital Preclinical Scientific Research Consultants, LLC, Bethesda, Maryland, USA.
Toxicol Pathol. 2019 Apr;47(3):329-338. doi: 10.1177/0192623318797289. Epub 2018 Oct 1.
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.
美国食品药品监督管理局器械与放射健康中心（FDA/CDRH）最近发布了几份体内测试指导文件，其中提到了改进、减少或替代动物试验的策略，以促进将大型动物安全性测试数据用于传统啮齿动物测试。为响应最近颁布的《食品药品监督管理局安全与创新法案》第907条，该条促进了对通常被称为突破性疗法认定的新型疗法的快速获取，FDA/CDRH讨论了首次人体研究的有效监管策略，包括早期可行性研究指导。通过FDA《国际标准化组织10993-1使用指南》中的示例，在人道护理和转化研究方面也可取得巨大进展，该指南指出，如果考虑并应用科学原理、方法和终点（SPME），大型动物安全性研究可被视为替代啮齿动物测试。本文讨论了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、诊断和病理数据来替代传统啮齿动物测试的SPME。建议包括考虑采用能对动物系统进行更全面整体询问的方法的研究设计。
