VICH GL43指导原则适用性研究

The Application of Target Animal Safety Guideline VICH GL43 in China

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.