VICH GL43指导原则适用性研究  

The Application of Target Animal Safety Guideline VICH GL43 in China

作　　者：李丹[1] 徐倩[1] 王学伟[1] 郭翱 娄瑞涵 梁先明[1] 汪霞[1] 苏富琴[1] LI Dan;XU Qian;WANG Xue-wei;GUO Ao;LOU Rui-han;LIANG Xian-ming;WANG Xia;SU Fu-qin(China Institute of Veterinary Drug Control,Beingjing 100081,China)

机构地区：[1]中国兽医药品监察所,北京100081

出　　处：《中国兽药杂志》2023年第7期56-61,共6页Chinese Journal of Veterinary Drug

基　　金：中国兽医药品监察所兽药行业公益性重点专项“兽用化学药品注册法规与指导原则研究”(GY202106)之课题“兽用化学药品VICH指导原则适用性研究”。

摘　　要：兽用药品注册技术要求国际协调会(VICH)指导原则转化是补充我国兽药技术指导原则的一种途径。对VICH GL43在我国兽药注册中的适用性进行研究,并与我国发布的相关指导原则技术要点进行比较,分析和讨论一般靶动物安全试验和其他情形靶动物安全性试验在动物选择、研究设计、给药方案、实验参数等方面的考虑和要求,并评估其适用性,为兽药研发和技术评审相关人员提供参考。The transformation and implementation of the International Coordination Committee on the Registration of veterinary drugs(VICH)guidelines is a supplement to the chinese veterinary drugs guidelines.In this paper,the applicability of VICH GL43 was evaluated by comparing the key technical points with the target animal safety guidelines released by China.The current considerations and requirements of animal selection,study design,drug administration,experimental parameters and other aspects in general target animal safety guideline and relevant special target animal safety guidelines were analyzed.This article provides a reference for veterinary drug developers and reviewers.

关 键 词：靶动物安全 VICH GL43 指导原则转化 适用性 

分 类 号：S851.66[农业科学—预防兽医学]