VICH兽药靶动物安全性研究指导原则概述

Overview of VICH Guideline of Target Animal Safety for Veterinary Pharmaceutical Products

VICH兽药靶动物安全性研究指导原则详尽地介绍了靶动物安全性研究的试验设计、实验方法和测定的变量,从2009年7月起在VICH地区实施。该指导原则是国际统一标准,按此指导原则所做的研究在VICH地区可得到相互承认。

This article briefly introduces VICH guideline of target animal safety for veterinary pharmaceutical products ,which is implemented from July 2009 in the VICH regions. Study design, experimental methods and the variables measured in the guideline have been described in detail. The guideline is an international harmonized standard. TAS studies done according to the guideline is mutually acceptable in VICH regions.