犬和猴单次给药毒性试验终末处置的考虑

随着中国药品监管体系与国际接轨，国际人用药品注册技术协调会（ICH）指导原则在中国相继转化实施。在非临床安全性评价研究阶段，开展单次给药毒性试验研究，所使用的大动物犬和猴是否在试验结束时必须处死，在充分考虑试验的合规性时，更要从动物福利与伦理，试验的科学性、必要性及利益平衡进行综合评估。在保证试验能够获得预期的信息达到试验目的同时，能够保障动物生存权利。

Considerations for end disposal of acute toxicity studies in dogs and monkeys

With China''s drug regulatory system in line with international standards, the ICH guiding principles have been transformed and implemented in China. In the non-clinical safety evaluation research phase, when conducting an acute toxicity studies, whether the large animal dogs and monkeys used must be sacrificed at the test bundle. When fully considering the compliance of the studies, we must also start with comprehensive evaluation of welfare and ethics, scientificity, necessity and balanced interests. While ensuring that the test can obtain the expected information to achieve the purpose of the test, the right to survival of the animal can be guaranteed.