对药品检验中常规动物实验福利伦理审查的必要性

目的 贯彻常规动物实验福利伦理审查制度,规范动物实验管理.方法 从法规、福利伦理审查内容、药典或相关技术规范对动物实验的规定等不同角度,结合我国实验动物发展现状,阐述对常规动物实验福利伦理审查的必要性和审查重点.结果与结论 对常规动物实验的福利伦理审查具有重要现实意义.     

基于3R原则探讨动物实验中人道终点的判定与应用

实验动物人道终点作为3R原则中优化原则的主要体现和应用,已被国际社会所认可并形成了完善的法律法规体系,伴随着我国在实验动物福利伦理方面所取得的巨大进步,实验动物人道终点的实践也得到了较大的应用和发展。通过对动物人道终点的判定原则和方法进行探讨,在最大程度保障动物福利的前提下,有效保证了动物实验数据的真实性、准确性和完整性,为从事动物实验的研究人员提供了一定的参考。     

GLP体系下实验动物兽医的培养与职责研究

随着我国医药工业的迅猛发展,药物非临床研究（GLP）工作也得到了快速发展,同时带动了实验动物科学和动物试验的迅速发展,实验动物的需求量越来越大。熟悉并掌握实验动物的饲养管理,疾病的预防、诊断、治疗及动物伦理福利的实验动物兽医的需求量也越来越大。因此,实验动物兽医在药物安全性评价实验室的重要性逐渐突显出来。下面结合本中心在实验动物兽医培养等方面的心得,探讨一下药物非临床研究体系下实验动物兽医的培养及职责。     

《实验动物福利与动物实验科学》出版

由11省市28单位60余位专家学者共同编写的《实验动物福利与动物实验科学》专著,已于2011年6月由科学出版社出版发行。本书包括上篇《实验动物福利与保护立法》和下篇《动物实验伦理与动     

浅谈医学生的实验动物福利教育

中国的发展日新月异,国际影响力与日俱增,但在实验动物福利教育方面与其他发达国家甚至发展中国家相比却有较大差距,既有损我国的国际形象,又与我国的政治经济和社会文明的进步不相协调。本文针对我国目前医学院校实验动物福利教育缺失的现状,比较系统地阐述了对医学生进行实验动物福利教育的意义,并提出了加强医科学生实验动物福利教育的具体做法。     

医学研究中实验动物福利伦理管理工作的分析与对策

<正>21世纪自然科学领域中,生命科学是发展最为迅速、科研成果最为显著的学科之一。实验动物作为生命科学研究和发展的重要基础和支撑,对医学发展和人类健康的科学研究具有十分重要的意义。动物实验为生命科学研究提供准确、可靠的实验基础数据,善待实验动物,完善实验动物的福利伦理,以及动物实验应符合伦理学原则等问题已引起广泛关注。从伦理学的角度去思考善待实验动物,一方面是生命科学研究的可持续性发展的需要,另一方面也体现了人类社会的文明进步。     

试论药品检验中实验动物的实验福利

实验动物福利工作的好坏,不仅反映实验动物学科建设的成就,而且影响着生物医学研究成果的社会性及公众认可程度。如何保证实验动物的福利,提高实验动物福利水平,正逐步成为社会公众所关注的一个热点〔1〕。     

影响医学实验动物福利的因素及改善措施

动物福利（animal welfare）的概念最早是由英国学者提出的,是指为保证动物健康安乐而采取的一系列行为,以及为其提供的相应外部条件,即动物与环境之间和谐共存,动物的精神和生理等方面健康;动物福利具体包含以下五项权利：①实验动物享有不受饥渴的权利：在饲养和实验过程中应为实验动物提供清洁的饮用水,以及保证其身体健康和精力旺盛所需的食物;②实验动物享有生活舒适的权利：在饲养和实验过程中应为实验动物提供清洁和舒适的栖息之所;     

药品临床前慢性毒理实验质量控制因素分析

药品临床前大鼠慢性毒性实验是药物非临床安全性研究的重要组成部分,是药物非临床毒理学研究中综合性最强、获得信息最多和对临床指导意义最大的研究。该文结合我国药品非临床前大鼠慢性毒理实验规定及实验室十余个大鼠慢性毒理学实验的经验和教训,分析探讨了实验中动物实验质量的控制问题。认为大鼠实验技术因素的质量控制和值得关注的影响动物实验结果的环境控制、动物福利控制、误差控制决定着大鼠慢性毒理学实验结果的客观性,直接影响药物的安全性评价结果,其标准化问题应引起新药研发人员及管理机构的重视。     

欧洲议会的动物实验政策平衡动物保护、医学研究及患者需求

欧洲议会以压倒性的544票赞成、66票反对、36票弃权通过一份有关欧盟未来动物实验的报告。对动物福利指令的审查由欧洲议会农业委员会进行，委员会主席Neil Parish（西南英格兰保守党人）为报告起草人，报告目标旨在改善动物福利并协调欧盟27个成员国的监管标准。投票结果发出一个强烈信号，即在6月份议会选举后及接下来的委员会选举后不会再提及该问题。     

Alternatives to animal testing: A review

The number of animals used in research has increased with the advancement of research and development in medical technology. Every year, millions of experimental animals are used all over the world. The pain, distress and death experienced by the animals during scientific experiments have been a debating issue for a long time. Besides the major concern of ethics, there are few more disadvantages of animal experimentation like requirement of skilled manpower, time consuming protocols and high cost. Various alternatives to animal testing were proposed to overcome the drawbacks associated with animal experiments and avoid the unethical procedures. A strategy of 3 Rs (i.e. reduction, refinement and replacement) is being applied for laboratory use of animals. Different methods and alternative organisms are applied to implement this strategy. These methods provide an alternative means for the drug and chemical testing, up to some levels. A brief account of these alternatives and advantages associated is discussed in this review with examples. An integrated application of these approaches would give an insight into minimum use of animals in scientific experiments.     

Ethical issues in the use of animals in biomedical and psychopharmocological research

Rationale The ethical debate concerning the use of animals in biomedical and pharmacological research continues to be replete with misunderstandings about whether animals have moral standing. Objectives This article briefly reviews the central ethical positions and their relationship to the basic parameters of research regulation from an international perspective. The issues associated with the validation of animal models will then be discussed. Finally, suggestions for empirical ethics research will be presented. Methods Recent literature reviews were accessed and analyzed. Results This review summarizes the pertinent ethical and research literature. Conclusions In summary, regardless of the ethical perspective one favors, there is strong agreement that animals matter morally and that at a minimum their welfare must be considered. This position is reflected in the structure of national regulatory schemes that emphasize the three Rs (replacement, reduction, refinement). Researchers should more actively participate in the discussion by becoming more knowledgeable about the details of the ethical issues. Research with animal models has been problematic in that it has often focused on attempting to produce global models of psychiatric disorders, which suffer from inherent validity problems. Researchers must also become more sophisticated about issues of model validation and the nature of the animals they use.     

通过GLP和AAALACi认证的新药安全评价实验动物管理

随着医药研发的全球化发展,国内新药安全评价机构获得药物非临床研究质量管理规范（GLP）和国际实验动物评估和认可管理委员会（AAALACi）双认证的越来越多。实验动物作为药物安全性评价的载体,其生存状态和动物福利将直接影响到试验结果,处理好两种体系下实验动物的饲养管理工作,是保证实验数据准确的必要条件。以天津药物研究院新药评价有限公司通过GLP和AAALACi两种体系认证的实际工作经验为基础,辅以与同行们的交流经验,探讨两种认证体系在实验动物管理工作中的关系,以期通过加强实验动物管理工作来保障新药安全评价工作的顺利进行。     

The search for alternatives

Animal welfare and antivivisection groups have protested against animal research for the last 150 years. However, they have recently (ca. 20 years ago) injected a new element into the debate by pressing for the development and application of alternatives. By this, they mean the development of techniques which could replace or reduce the use of laboratory animals, or the refinement of existing techniques to reduce animal suffering. Animal welfare concerns have focused on toxicology testing in particular. Of course, the state of the art in toxicology has advanced considerably in the last 20 years and some of the changes have resulted in a reduction of the use of animals. Nevertheless, the animal welfare movement seeks a more specific program which will review testing guidelines and support the development of new techniques which will reduce or eliminate animal use. Carcinogen detection, Draize eye irritancy testing, and LD50 testing are three specific areas where the pressure for alternatives development has been strongest. The prospects for alternatives in each of these three are briefly discussed together with one or two comments about possible future trends.     

犬和猴单次给药毒性试验终末处置的考虑

随着中国药品监管体系与国际接轨,国际人用药品注册技术协调会（ICH）指导原则在中国相继转化实施。在非临床安全性评价研究阶段,开展单次给药毒性试验研究,所使用的大动物犬和猴是否在试验结束时必须处死,在充分考虑试验的合规性时,更要从动物福利与伦理,试验的科学性、必要性及利益平衡进行综合评估。在保证试验能够获得预期的信息达到试验目的同时,能够保障动物生存权利。     

医药院校增强实验动物伦理教育的调查与思考

动物实验在生命科学和医学发展的进程中是必不可少的。国内医学生的实验动物伦理教育还非常薄弱,因此医学生存在漠视动物痛苦、不了解动物权利的情况,教师在教学中经常忽视该方面的教育和引导。通过调查对比,本文发现在实验课随堂开展实验动物伦理教育,不但让学生了解实验动物权利的意义,培养学生对生命的尊重感,为培养良好的医德建立伦理和心理基础。而且改变了医学生对实验教学的态度,有效的提高了教学的效果。     

Animal experimentation: the continuing debate

The use of animals in research and development has remained a subject of public debate for over a century. Although there is good evidence from opinion surveys that the public accepts the use of animals in research, they are poorly informed about the way in which it is regulated, and are increasingly concerned about laboratory-animal welfare. This article will review how public concerns about animal experimentation developed, the recent activities of animal-rights groups, and the opportunities and challenges facing the scientific community.