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如何通过应用良好的监管使用方法实践来促进3D模型在中国的实施。

How to facilitate the implementation of 3D models in China by applying good method practice for regulatory use.

作者信息

Liu Yanfeng, Cai Zhenzi, Li Nan, Alépée Nathalie

机构信息

L'Oréal Research & Innovation China, Shanghai, China.

L'Oréal Research & Innovation France, Aulnay-Sous-Bois, France.

出版信息

Front Toxicol. 2023 Mar 8;5:1080528. doi: 10.3389/ftox.2023.1080528. eCollection 2023.

DOI:10.3389/ftox.2023.1080528
PMID:36969263
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10032455/
Abstract

The Organization for Economic Co-operation and Development (OECD) Guidance Document No. 34 and No. 286 on Good Method Practices (GIVIMPs) for the development and implementation of methods for regulatory use in human safety assessment have been endorsed. Considering that China is accelerating the development of alternative approaches in both research and acceptance, early application of these principles is beneficial to the implementation and acceptance of alternative methods in China. To promote the replacement of animal testing for regulatory use, L'Oréal initiated the EpiSkin™ skin irritation test (SIT) implementation program in China. More than 50 external scientists participated, and the method has been established in 34 organizations including authorities, industries, and testing service laboratories. Taking two collaborations with Guangdong CDC and Shanghai SGS for SIT as examples, we demonstrated a method implementation process in good alignment with the OECD principles. The current study illustrated the practical way in which both OECD Guidance documents assisted in the transfer and establishment of approaches and further promoted the future scientific recognition and acceptance of new OECD-accepted alternative testing methodologies in China.

摘要

经济合作与发展组织(OECD)关于人类安全评估监管用途方法开发与实施的良好方法实践(GIVIMPs)的第34号和第286号指导文件已获认可。鉴于中国正在加速替代方法在研究和认可方面的发展,尽早应用这些原则有利于替代方法在中国的实施和认可。为推动监管用途动物试验的替代,欧莱雅在中国启动了EpiSkin™皮肤刺激试验(SIT)实施项目。50多名外部科学家参与其中,该方法已在包括当局、行业和检测服务实验室在内的34个组织中确立。以与广东省疾控中心和上海通标标准技术服务有限公司就SIT开展的两项合作为例,我们展示了一个与经合组织原则高度一致的方法实施过程。当前的研究说明了经合组织这两份指导文件如何协助方法的转移和确立,并进一步推动中国未来对经合组织新认可的替代测试方法的科学认可和接受。

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3
Employment of cytology for in vitro skin irritation test using a reconstructed human epidermis model, Keraskin™.
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