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将3R方法纳入世界卫生组织生物制品批签发检测指南:一系列NC3R利益相关方研讨会的报告

Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Reports from a series of NC3Rs stakeholder workshops.

作者信息

Lilley Elliot, Isbrucker Richard, Holmes Anthony

机构信息

NC3Rs, London, United Kingdom.

Health Canada, Canada.

出版信息

Biologicals. 2025 Feb;89:101777. doi: 10.1016/j.biologicals.2024.101777. Epub 2024 Dec 20.

DOI:10.1016/j.biologicals.2024.101777
PMID:39708626
Abstract

A recent report presented to the WHO has highlighted significant opportunities for the implementation of 3Rs approaches (i.e. Replacement, Reduction and Refinement of animal tests) within their manuals, guidelines and recommendations for vaccines and biotherapeutics. The report is the culmination of a three-year project led by the UK National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) and co-funded by the Bill & Melinda Gates Foundation. The aim was to review the extent to which animal-based testing methods are currently described in these internationally recognised guidance documents and recommend opportunities for applying the 3Rs. International stakeholders have been engaged throughout the project to gauge opportunities and barriers to adoption of 3Rs approaches and how these vary globally, to inform the recommendations in the report. This paper summarises the output from a series of international stakeholder workshops held between March 2022 and September 2023.

摘要

最近提交给世界卫生组织的一份报告强调了在其疫苗和生物治疗手册、指南及建议中实施3R方法(即替代、减少和优化动物试验)的重大机遇。该报告是由英国国家动物研究替代、优化与减少中心(NC3Rs)牵头、比尔及梅琳达·盖茨基金会共同资助的一个为期三年项目的成果。其目的是审查这些国际认可的指导文件中目前对基于动物的测试方法的描述程度,并推荐应用3R方法的机会。在整个项目过程中,国际利益相关者参与其中,以评估采用3R方法的机遇和障碍以及这些在全球范围内的差异,为报告中的建议提供信息。本文总结了2022年3月至2023年9月期间举办的一系列国际利益相关者研讨会的成果。

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