参考产品及世界卫生组织国际标准/参考试剂在类似生物制品（生物类似药）研发中的预期用途。
Intended use of reference products & WHO International Standards/Reference Reagents in the development of similar biological products (biosimilars).
作者信息
Thorpe Robin, Wadhwa Meenu
机构信息
Biotherapeutics Group, National Institute for Biological Standards and Control (NIBSC), Blanche Lane, South Mimms, Potters Bar, Herts, UK.
出版信息
Biologicals. 2011 Sep;39(5):262-5. doi: 10.1016/j.biologicals.2011.06.005. Epub 2011 Aug 30.
Abstract
Reference Products and WHO International Standards/Reference Reagents have roles to play in the development and characterization of similar biological products (SBPs). However, these roles are distinct and non-interchangeable. The uses of these materials and their limitations are considered in this paper.
摘要
参考产品以及世界卫生组织国际标准品/参考试剂在相似生物制品（SBPs）的研发和特性鉴定中发挥着作用。然而，这些作用是不同的且不可相互替代。本文探讨了这些材料的用途及其局限性。
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