Strategic focus on 3R principles reveals major reductions in the use of animals in pharmaceutical toxicity testing.
Strategic focus on 3R principles reveals major reductions in the use of animals in pharmaceutical toxicity testing.
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DOI：
10.1371/journal.pone.0101638
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发表时间：
2014
期刊：
影响因子：
3.7
通讯作者：
Öberg M
中科院分区：
文献类型：
--
作者：
Törnqvist E;Annas A;Granath B;Jalkesten E;Cotgreave I;Öberg M
为保障动物福利，“替代”、“减少”和“改良”的原则正越来越多地纳入动物实验的立法、指引和实践中。在本研究中，我们研究了3R原则在制药行业毒理学研究中的系统应用，特别侧重于减少用于监管和研究性体内研究的动物数量。这项工作还详细说明了影响这些削减的主要因素，包括构想、跨部门工作和工作过程的接受程度。从2006年至2010年的36个减排项目中回顾性收集了数据。通过不同的策略，包括改进研究设计、方法开发和项目协调，实现了动物使用量的大幅减少。在监管和调查安全研究中都显示了主要的动物节省。如果在12家最大的制药公司中同时实现类似的（即53%）减少，那么全世界每年将减少约15万只老鼠。研究结果表明了强大的3R文化的重要性，其中科学参与、协作和响应式管理是至关重要的组成部分。建议在领导3R方面的坚定承诺转化为跨部门和跨专业参与创新，验证和实施项目。观察到所有三个R之间的协同作用，并得出结论，在硅、体外和体内的方法都具有应用还原R的潜力，因此应在战略层面进行协调。
The principles of the 3Rs, Replacement, Reduction and Refinement, are being increasingly incorporated into legislations, guidelines and practice of animal experiments in order to safeguard animal welfare. In the present study we have studied the systematic application of 3R principles to toxicological research in the pharmaceutical industry, with particular focus on achieving reductions in animal numbers used in regulatory and investigatory in vivo studies. The work also details major factors influencing these reductions including the conception of ideas, cross-departmental working and acceptance into the work process. Data from 36 reduction projects were collected retrospectively from work between 2006 and 2010. Substantial reduction in animal use was achieved by different strategies, including improved study design, method development and project coordination. Major animal savings were shown in both regulatory and investigative safety studies. If a similar (i.e. 53%) reduction had been achieved simultaneously within the twelve largest pharmaceutical companies, the equivalent reduction world-wide would be about 150,000 rats annually. The results point at the importance of a strong 3R culture, with scientific engagement, collaboration and a responsive management being vital components. A strong commitment in leadership for the 3R is recommended to be translated into cross-department and inter-profession involvement in projects for innovation, validation and implementation. Synergies between all the three Rs are observed and conclude that in silico-, in vitro- and in vivo-methods all hold the potential for applying the reduction R and should be consequently coordinated at a strategic level.
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