摘要
介绍了"动物法则"的产生背景和内容,以及美国FDA根据"动物法则"进行炭疽等不能在人体进行临床试验的疾病防治药物和生物制品审批时的相关要求。从产品特性、动物有效性实验结果及使用时的注意事项等方面对近年来美国食品药品监督管理局根据"动物法则"批准上市的一些产品进行简述。综述表明,"动物法则"对产品开发者提出严格要求的同时,建议开发者在开发前后的一系列过程中都要时刻保持与FDA的密切交流,设计研发出解决实际问题的产品。
This article describes the background and content of the ＂animal rule＂, and the relevant requirements of the FDA for the approval of disease prevention drugs and biological products that cannot be used for clinical experiments in the human body, such as anthrax, based on the ＂animal rule＂. In this paper, some products approved by FDA according to ＂animal rule＂ in recent years are briefly introduced, including product characteristics, experimental results of animal effectiveness and matters needing attention in use. The summary shows that ＂animal rule＂ puts forward strict requirements for product developers, at the same time, it is suggested that developers should keep close communication with FDA in a series of processes before and after development, and design and develop products to solve practical problems.
作者
高明
焦磊
王秉翔
GAO Ming;JIAO Lei;WANG Bing-xiang(No.3 Research Laboratory,Lan Zhou Institute of Biological Products Co.,Ltd.,Center for Gansu Provincial Vaccine Engineering Research,Lanzhou 730046,China)
出处
《中国人兽共患病学报》
CAS
CSCD
北大核心
2018年第8期737-742,共6页
Chinese Journal of Zoonoses
基金
“重大新药创制”重大科技专项(No.20142X09102047)
