摘要
结合金标类体外诊断试剂本身的特点,从审评、现场检查、研发、生产的角度出发,列举一些在设计开发过程中可能会出现的问题,并针对这些问题进行分析,旨在为企业在具体操作层面应加强的关注点提供技术参考。
Combined with the characteristics of colloidal gold in vitro diagnostic reagent itself,from certification,on-site inspection,research and development,production,this paper enumerates some problems that may occur in the process of design and development,and analyzes these problems.The purpose of this paper is to provide technical reference for enterprises to strengthen their concerns at the specific operational level.
作者
戴清
张绍千
张苏琳
吴猛
吴浩
张莉莉
DAI Qing;ZHANG Shao-qian;ZHANG Su-lin;WU Meng;WU Hao;ZHANG Li-li(Jiangsu Province Food and Drug Administration Certification and Evaluation Center,Jiangsu Nanjing 210002;Jiangsu Drug Administration,Jiangsu Nanjing 210008;New Drug Application Service Center of Taizhou Pharmaceutical High-tech Industrial Park,Jiangsu Taizhou 225300)
出处
《中国医疗器械信息》
2020年第21期1-2,40,共3页
China Medical Device Information
关键词
体外诊断试剂
胶体金
设计开发
in vitro diagnostics reagents
colloidal gold
design and development
