浅谈已有国家标准的化学药品研发的质量控制和技术要求  

Discussion About Quality Control and Technical Requirement of the Chemicals of the Obtained Official Standard

作　　者：于大海[1] 苏佳妍[2] 

机构地区：[1]辽宁省食品药品检验所,沈阳110023 [2]中国医科大学第一临床学院

出　　处：《中国药事》2008年第3期209-213,共5页Chinese Pharmaceutical Affairs

摘　　要：目前,仿制已有国家标准药品的研制开发工作,在质量研究方面存在的差异较大。从6类化学药品方面,对申报的已有国家标准药品的原料和制剂质量研究中的重要问题进行讨论,从而达到使仿制药品的研发工作进一步提高、完善与规范的目的。Today, a large difference exists in quality study during the development of the chemicals of the obtained official standard. In order to raise, consummate and specify the study of the replicated chemicals, the significant problems during the quality research about the raw material and preparation of the obtained official standard have been discussed from class six of the chemicals.

关 键 词：已有国家标准 质量研究 技术要求 

分 类 号：R95[医药卫生—药学]