小型猪在新药安全性评价中的应用展望

Prospect of application of minipigs in drug safety evaluation

小型猪是新药安全性评价中可选择的大动物物种之一,但限于动物来源、背景数据及操作等原因,目前小型猪在安全性评价中并未得到广泛使用。本文分析了小型猪的自身特点,并结合新药申报政策,对小型猪在安全性评价中的应用进行综述,以期小型猪可以作为大动物物种选择的一种补充,必要时替代犬或非人灵长类,解决新药研发过程中的实际问题和特殊情况。

Minipig is one of optional large animal species in new drug safety evaluation. However,due to the limited animal resource,lack of background data,and operational challenges,the application of minipigs in safety evaluation is largely limited to drugs for dermal administration. In this article,we reviewed the physiological characteristics as well as the utility of minipigs in regulatory toxicity testing. Overall,this review leads us to believe that minipigs can substitute dogs or non-human primates as a non-rodent species under certain circumstances in drug safety evaluation.