摘要
随着我国对药品质量标准提高工作的日益重视,生物技术类制品的质量标准日臻完善,与国外先进水平的差距正在逐步缩小。本文分析比较了现行版《中国药典》与《欧洲药典》中生物技术类制品标准的主要差异,探讨了我国生物技术类制品质量标准的发展方向。
With the increasing attention paid to the improvement of drug quality standards in China, the quality standards of bioteclmological products have been enhanced and the gap between the official standards at home and abroad is being narrowed. The paper briefly described the main differences between the quality requirements of biotechnological products in the current Chinese and European Pharmacopeias, and the directional development of the improvement of drug quality standards was explored.
出处
《中国执业药师》
CAS
2012年第9期60-64,共5页
China Licensed Pharmacist
关键词
生物技术类制品
质量标准
药典
Biotechnological Products
Quality Standards
Pharmacopeia
