Discussion and Concern on Animal Study for Orthopaedic Implantable Devices.
10.3969/j.issn.1671-7104.2023.05.016
- Author:
Jiazhen ZHANG
1
;
Bao ZHAI
1
;
Ruhan A
1
;
Le JIN
1
;
Yajuan GUO
1
;
Xinli SHI
1
Author Information
1. Center for Medical Device Evaluation, NMPA, Beijing, 100081.
- Publication Type:Journal Article
- Keywords:
3R principle;
animal study;
orthopaedic implantable device;
safety and effectiveness;
systematic review
- MeSH:
Animals;
Orthopedics;
Biocompatible Materials;
Prostheses and Implants;
Research Design
- From:
Chinese Journal of Medical Instrumentation
2023;47(5):550-556
- CountryChina
- Language:Chinese
-
Abstract:
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.
