供应NIBSC17/236可溯源阿达木单抗国际标准物质
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The World Health Organization (WHO) Expert Committee on Biological standardization (ECBS) recognised the need for a reference standard to evaluate the performance of in vitro biological assays for adalimumab.The International Standard 17/236 is intended to support the calibration,characterisation and validation of assays used for assessing adalimumab and to support the establishment of in-house standards.The standard was assessed in an international collaborative study (described in section 3), for in vitro biological activities of adalimumab. The standard was also assessed for use in assays for therapeutic drug monitoring.
The preparation contains material of human origin, and either the final product or the source materials, from which it is derived, have been tested and found negative for HBsAg, anti-HIV and HCV RNA. As with all materials of biological origin, this preparation should be regarded as potentially hazardous to health. It should be used and discarded according to your own laboratory’s safety procedures. Such safety procedures should include the wearing of protective gloves and avoiding the generation of aerosols. Care should be exercised in opening ampoules or vials, to avoid cuts. NIBSC17/236
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评估阿达木单抗体外生物检测的性能。国际标准17/236旨在支持校准，用于评估阿达木单抗和支持建立内部标准的分析的表征和验证。该标准在一项国际合作研究中进行了评估（如第3节所述），用于阿达木单抗的体外生物活性。该标准还被评估用于治疗药物监测的测定。 可溯源阿达木单抗国际标准物质
该制剂含有人类来源的材料，其最终产物或来源材料经过测试，发现HBsAg、抗HIV和HCV RNA呈阴性。与所有生物来源的材料一样，这种制剂应被视为对健康有潜在危害。应根据您自己实验室的安全程序使用和丢弃它。此类安全程序应包括佩戴防护手套和避免产生气溶胶。打开安瓿或小瓶时应小心，以避免割伤。
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