隨著中國藥品監(jiān)管體系與國際接軌，國際人用藥品注冊技術(shù)協(xié)調(diào)會（ICH）指導(dǎo)原則在中國相繼轉(zhuǎn)化實(shí)施。在非臨床安全性評價(jià)研究階段，開展單次給藥毒性試驗(yàn)研究，所使用的大動物犬和猴是否在試驗(yàn)結(jié)束時(shí)必須處死，在充分考慮試驗(yàn)的合規(guī)性時(shí)，更要從動物福利與倫理，試驗(yàn)的科學(xué)性、必要性及利益平衡進(jìn)行綜合評估。在保證試驗(yàn)?zāi)軌颢@得預(yù)期的信息達(dá)到試驗(yàn)?zāi)康耐瑫r(shí)，能夠保障動物生存權(quán)利。

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.

R965.3