摘要
稳定性作为检测体系的关键技术指标之一,对体外诊断试剂的安全有效具有重要的指导意义。本文从诊断试剂上市前研究过程中涉及到的稳定性类型及相关要求方面,对其进行了阐述。
Stability is one of the key technical indexes of the detection system,which is of great significance to the safety and effectiveness of in vitro diagnostic reagents.The stability types of in vitro diagnostic reagents were discussed here,as well as the related requirements which should meet before marketing.
作者
徐加发
蔡瑶
XU Jia-fa;CAI Yao(Jiangsu Bioperfectus Technology Co., Ltd.Jiangsu Taizhou 225300;Jiangsu Provincial Food and Drug Administration Certification and Evaluation Center,Jiangsu Nanjing 210002)
出处
《中国医疗器械信息》
2017年第15期30-32,共3页
China Medical Device Information
关键词
体外诊断试剂
稳定性
in vitro diagnostic reagents
stability
