| 摘要: |
| 兽药的使用不但要保障靶动物的安全，更要保障人的食品消费安全，因此，兽药新化药研发的临床前安全评价与人用药物相比，有其独特的特点。每日允许摄入量、兽药最高残留限量和休药期的制定是兽药独有的内容。本文比较了兽药和人用药物在临床前安全评价 内容的差异，为从事新药研发的毒理学工作者提供参考。 |
| 关键词: 临床前安全评价 兽药 人用药物 |
| DOI： |
| 投稿时间：2013-03-22修订日期：2013-06-09 |
| 基金项目: |
|
| The difference of the new drug safety evaluation between new medicine using for animals and human |
|
| (China Institute of Veterinary Drugs Control) |
| Abstract: |
| The purpose of using veterinary drug not only to guarantee the safety of the target animals but also to safeguard the food safety of consumer. Therefore, the preclinical safety evaluation content of new veterinary medicine has its unique features including acceptable daily intake(ADI), maximum residue limits(MRL) and withdrawal period compared with the new human medicinal products. Understanding the differences can provide a reference for the new medicine R |
| Key words: preclinical safety evaluation veterinary drug Human Medicinal Products |
