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首页> 外文期刊>Biologicals: Journal of the International Association of Biological Standardization >Report on the international workshop on alternatives to the murine histamine sensitization test (HIST) for acellular pertussis vaccines: state of the science and the path forward.
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Report on the international workshop on alternatives to the murine histamine sensitization test (HIST) for acellular pertussis vaccines: state of the science and the path forward.

机译：关于鼠组胺敏化试验（神节）的国际研讨会的报告用于无细胞植物疫苗：科学状态和前进的道路。

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摘要

Regulatory authorities require safety and potency testing prior to the release of each production lot of acellular pertussis (aP)-containing vaccines. Currently, the murine histamine sensitization test (HIST) is used to evaluate the presence of residual pertussis toxin in aP containing vaccines. However, the testing requires the use of a significant number of mice and results in unrelieved pain and distress. NICEATM, ICCVAM, their partners in the International Cooperation on Alternative Test Methods, and the International Working Group for Alternatives to HIST organized a workshop to discuss recent developments in alternative assays to the HIST, review data from an international collaborative study on non-animal alternative tests that might replace the HIST, and address the path toward global acceptance of this type of method. Currently, there are three potential alternative methods to HIST. Participants agreed that no single in?vitro method was sufficiently developed for harmonized validation studies at this time. It is unlikely that any single in?vitro method would be applicable to all aP vaccines without modification, due to differences between vaccines. Workshop participants recommended further optimization of cell-based assays under development. Participants agreed that the next international collaborative studies should commence in 2013 based on discussions during this workshop.
机译：监管机构在释放每种生产大量的无细胞植物（AP）疫苗之前需要安全性和效力测试。目前，鼠组胺敏化试验（HEST）用于评估含有疫苗的AP中残留百日咳毒素的存在。然而，测试需要使用大量的小鼠并导致未缓解的疼痛和痛苦。尼古姆，ICCVAM，他们在替代测试方法的国际合作中的合作伙伴，以及SUIT的替代方案的国际工作组组织了一个讲习班，讨论了替代替代分析的最新发展，从国际合作研究中审查了关于非动物替代的国际合作研究可能更换SIST的测试，并解决了对这种类型方法的全局接受的路径。目前，SIST有三种潜在的替代方法。参与者同意在此时没有充分开发单一的体外方法以进行协调验证研究。由于疫苗之间的差异，不太可能在没有改性的情况下适用于所有AP疫苗。研讨会参与者建议在开发中进一步优化基于细胞的测定。与会者同意，下一个国际合作研究应在2013年开始基于本讲习班的讨论。

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