作者
Mark B Hurtig, Michael D Buschmann, Lisa A Fortier, Caroline D Hoemann, Ernst B Hunziker, Jukka S Jurvelin, Pierre Mainil-Varlet, C Wayne McIlwraith, Robert L Sah, Robert A Whiteside
发表日期
2011/4
期刊
Cartilage
卷号
2
期号
2
页码范围
137-152
出版商
Sage Publications
简介
Investigational devices for articular cartilage repair or replacement are considered to be significant risk devices by regulatory bodies. Therefore animal models are needed to provide proof of efficacy and safety prior to clinical testing. The financial commitment and regulatory steps needed to bring a new technology to clinical use can be major obstacles, so the implementation of highly predictive animal models is a pressing issue. Until recently, a reductionist approach using acute chondral defects in immature laboratory species, particularly the rabbit, was considered adequate; however, if successful and timely translation from animal models to regulatory approval and clinical use is the goal, a step-wise development using laboratory animals for screening and early development work followed by larger species such as the goat, sheep and horse for late development and pivotal studies is recommended. Such animals …
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