摘要
近年来,骨科植入器械领域新产品不断涌现,对产品技术审评提出了更高要求,动物研究作为部分新型骨科植入器械研发过程的重要环节,为产品的设计定型提供相关证据支持。该研究通过介绍骨科植入器械研发涉及的动物研究,及3R原则(替代、减少、优化)在该领域中的应用,对动物研究时重点关注的问题进行总结归纳,以期为新型骨科植入器械和生物材料的动物试验开展和研究提供参考。同时,对系统评价等循证研究方法在骨科植入器械领域的应用进行介绍,以期为骨科植入医疗器械监管及审评科学提供新工具、新方法。
In recent years,new orthopaedic implantable devices continue to emerge,which require higher requirements for technical evaluation.Animal study is an important part of the research and development process for the new orthopedic implantable devices,which provides relevant evidence for product design and stereotyping.By introducing the purpose of animal study,and the application of 3R principle(replacement,reduction,refinement)in this field,we summarize the concern on the animal study,in order to provide reference for the development and research of new orthopedic implantable devices and biomaterials.At the same time,the application of evidence-based research methods such as systematic review in the field is introduced,which provides new tools and approaches for the technical review and regulatory science.
作者
张家振
翟豹
阿茹罕
金乐
郭亚娟
史新立
ZHANG Jiazhen;ZHAI Bao;A Ruhan;JIN Le;GUO Yajuan;SHI Xinli(Center for Medical Device Evaluation,NMPA,Beijing,100081)
出处
《中国医疗器械杂志》
2023年第5期550-556,共7页
Chinese Journal of Medical Instrumentation
关键词
骨科植入器械
动物研究
3R原则
系统评价
安全有效
orthopaedic implantable device
animal study
3R principle
systematic review
safety and effectiveness
作者简介
张家振,E-mail:zhangjz@cmde.org.cn。
