Kojima Hajime
Department of Pharmaceutical Engineering, Faculty of Engineering, Sanyo-Onoda City University, 1-1-1, Daigaku-dori, Sanyo-Onoda City, 756-0884, Yamaguchi, Japan.
National Institute of Health Sciences, Kawasaki, Japan.
Genes Environ. 2025 Jan 29;47(1):3. doi: 10.1186/s41021-024-00323-7.
The number of alternatives to animal tests (non-animal test methods) for human health developed globally account for more than 40% of the test methods in the Organisation for Economic Co-operation and Development (OECD) Guidelines for the Testing of Chemicals (TGs). Within the TGs, the National Institute of Health Sciences (NIHS) has standardized 16 OECD TGs for human health, implemented four major revisions, and developed one test method for the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) S10 guidelines on photosafety. This review describes trends in the OECD and Japan that mainly focus on international standardizations of non-animal test methods for human health. Drawing from this experience, I hope Japan will advance new approach methodologies for detecting systemic toxicity, which are in global demand.
全球开发的用于人类健康的动物试验替代方法(非动物试验方法)数量,占经济合作与发展组织(OECD)《化学品测试指南》(TGs)中测试方法的40%以上。在这些TGs中,国立卫生科学研究所(NIHS)已将16项OECD人类健康TGs标准化,进行了四项重大修订,并为国际人用药品注册技术协调会(ICH)关于光安全性的S10指南制定了一种测试方法。本综述描述了OECD和日本主要关注人类健康非动物试验方法国际标准化的趋势。借鉴这一经验,我希望日本能推进全球需求的用于检测全身毒性的新方法学。