The objectives of the cooperation are to increase awareness of the importance of quality and safety of medicine, establish a basis for and mechanisms of collaboration between USP and NICPBP, share a common goal of imp...
详细信息
The objectives of the cooperation are to increase awareness of the importance of quality and safety of medicine, establish a basis for and mechanisms of collaboration between USP and NICPBP, share a common goal of improving the quality of medicines in China and the United States.
标准物质是生物制品质量控制和评价的标尺。世界卫生组织（World Health Organization,WHO）标准物质指南和手册、国家标准物质管理规程、药典等技术文件对生物标准物质研制、分发及使用发挥重要指导作用。为适应生物制品行业发展的需要...
详细信息
标准物质是生物制品质量控制和评价的标尺。世界卫生组织（World Health Organization,WHO）标准物质指南和手册、国家标准物质管理规程、药典等技术文件对生物标准物质研制、分发及使用发挥重要指导作用。为适应生物制品行业发展的需要，WHO和我国生物标准物质相关指南及管理规程均经历了多次修订。本文对WHO国际生物标准物质和我国国家生物标准物质定义、分类以及技术要求的沿革和现状作一总结，以期进一步提升我国国家生物标准物质的研制和应用水平。
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