药物毒理学研究中体外替代试验研究现状及展望

药物的安全性和有效性是药物研发成功的决定因素,而药物毒性是终止药物研发的关键因素之一。相关监管指南和指导原则为利用动物进行毒理学研究及生物测试或其他相关试验制定了基本标准。动物体外替代试验不仅遵守了国际上提倡的“3R原则”,也符合毒理学学科发展、社会经济发展及新药研发的要求。动物体外替代试验已成为21世纪毒性测试的重要方向,毒性测试的重点将集中在敏感性终点的选择与评价、细胞-反应网络、高通量与中通量筛选方法的构建及应用、作用机制及作用模式、毒性通路以及系统生物学效应等方面,并且已获得药物研发领域广泛的支持和监管部门的认可,具有广阔的发展前景和重要的应用价值。

Current situation and prospects of in vitro alternative tests in drug toxicological study

The safety and efficacy of drugs are the determinants of the success of drug discovery and development, and drug toxicity is one of the key factors in stopping drug development. The relevant regulatory guidelines and principals establish basic standards for the use of animals for toxicological studies and biological tests or other related tests. In vitro alternative tests not only comply with the internationally promoted "3R Principles", but also the needs and scientific requirements for the development of toxicology disciplines, socio-economic development and the development of emerging therapeutic methods. In vitro animal alternative testing has become an important direction for toxicity testing in the 21st century. The focus of toxicity testing will focus on the selection and evaluation of sensitive endpoints, cell-response networks, the construction and application of high- and medium-throughput screening methods, mechanisms of action and modes of action, toxic pathways, and system biology effects, etc.. In vitro alternative test is being widely recognized and approved by the regulatory authorities, and has broad prospects for development and important application value.