供应NIBSC17/204可溯源达依泊汀国际标准物质
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The World Health Organisation (WHO) Expert Committee on Biological Standardisation (ECBS) has recognised the need for a reference standard for the calibration of in vitro potency assays to assess the biological activity of darbepoetin. A candidate standard, coded 17/204, was evaluated in an international collaborative study, based on which the preparation was formally adopted by WHO ECBS in October 2019 as the 1st International Standard for darbepoetin. NIBSC17/204
This standard is intended to support the performance of in vitro bioassays of darbepoetin, by definition of the International Unit (IU) of darbepoetin biological activity. It is not intended to serve any regulatory role in defining biosimilarity, nor is the assigned IU intended to define the specific activity (U/mg) of darbepoetin for regulatory purposes, or describe the dosage or labelling of darbepoetin products. 可溯源达依泊汀国际标准物质
世界卫生组织（WHO）生物标准化专家委员会（ECBS）认识到需要一个参考标准来校准体外效价测定，以评估达贝泊汀的生物活性。在一项国际合作研究中评估了一个候选标准，编号为17/204，根据该研究，该制剂于2019年10月被世界卫生组织欧洲标准化委员会正式采用，成为第一个达贝泊汀国际标准。
本标准旨在根据达必泊汀生物活性的国际单位（IU）的定义，支持达必泊素的体外生物测定性能。它不打算在定义生物相似性方面发挥任何调节作用，指定的IU也不打算为了调节目的定义达必泊汀的比活性（U/mg），或描述达必泊素产品的剂量或标签。
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