| 摘要: |
| VICH“兽药靶动物安全性研究指导原则”从2009年7月起在VICH地区实施。该指导原则是国际统一标准。按此指导原则所做研究在VICH地区可得到相互承认。本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，实用性极强。本文予以简介。 |
| 关键词: VICH IVVP 靶动物 安全性 指导原则 |
| DOI： |
| 投稿时间：2009-10-26修订日期：2009-11-04 |
| 基金项目: |
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| Overview of VICH Guideline “Target Animal Safety for Veterinary Pharmaceutical Products” |
| Xiao Hui-lai |
| (Center for Drug Evaluation, State Food and Drug Administration) |
| Abstract: |
| VICH Guideline “Target Animal Safety for Veterinary Pharmaceutical Products” is implemented from July 2009 in the VICH regions. The Guideline is an international harmonized standard. TAS studies done according to the Guideline is mutually acceptable in VICH regions. Study design, experimental methods and the variables measured in the guideline have been described in detail. This article introduces it briefly. |
| Key words: VICH IVVP target animal safety guideline |
