| "抗菌新兽药对与人类健康相关细菌微生物学影响的安全性评价"指导原则简介 |
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| 引用本文： | 萧惠来."抗菌新兽药对与人类健康相关细菌微生物学影响的安全性评价"指导原则简介[J].中国兽药杂志,2005,39(7):11-15. |
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| 作者姓名： | 萧惠来 |
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| 作者单位： | 国家食品药品监督管理局药品审评中心,北京,100038 |
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| 摘 要： | 在食品动物使用抗菌药,可能导致耐药菌产生,耐药菌在人畜间的传递导致产生交叉耐药性.FDA对此制定了安全性评价指导原则.本文简要介绍了抗菌新兽药对与人类健康相关细菌微生物学影响的安全性评价指导原则.该指导原则主要内容包括:释放评价、暴露评价、后果评价、危险评估及危险管理措施制定等.毫无疑问,这一指导原则对我国抗菌新兽药管理和食品安全管理会有所启迪.
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| 关 键 词： | 抗菌药 安全性评价 指导原则 |
| 文章编号： | 1002-1280(2005)07-0011-05 |
| 修稿时间： | 2005年4月30日 |
Brief introduce of the guidance-evaluating the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern |
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| XIAO Hui-lai.Brief introduce of the guidance-evaluating the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern[J].Chinese Journal of Veterinary Drug,2005,39(7):11-15. |
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| Authors: | XIAO Hui-lai |
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| Abstract: | The use of antimicrobial animal drugs in food-producing animal will result in emergence and selection antimicrobial resistant food-borne bacteria which impact human health adversely. For this reason the guidance has been prepared by the Food and Drug Administration of USA. This article describes the guidance briefly. The risk assessment process which described in this guidance is comprised mainly of a release assessment, an exposure assessment, a consequence assessment, a risk estimation, and identifying steps necessary to mange the risk. The guidance will enlighten our country on the management of antimicrobial animal drugs and microbial food safety. |
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| Keywords: | Antimicrobial drugs risk assessment guidance |
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