PET/CT动物实验相关问题的思考

      Consideration on Animal Experiment in PET/CT

      • 摘要: PET/CT成像可反映活体的生理代谢过程,仅靠模体实验无法模拟生理代谢情况。在对PET/CT产品进行系统确认时,可以考虑动物实验。获得的研究数据可用于PET/CT产品的可行性、有效性、安全性评价,作为研究资料或临床评价资料的支持性文件在产品注册或注册变更时提交。阐述了动物实验的作用和优势,提出了应关注的问题,列举了相关研究示例,为PET/CT产品的验证确认及产品评价提供参考。

         

        Abstract: PET/CT imaging can reflect the physiological metabolic process in living body which is the model experiment incapable to simulate. Animal experiment may be considered for systematic validation of PET/CT products. The obtained research data can be used to evaluate the feasibility, effectiveness and safety of PET/CT products, and be submitted as supporting documents for research data or clinical evaluation data when doing product registration or alteration registration. In this study, the functions and advantages of animal experiments were expounded, and relevant research cases were given as well as the issues that should be paid attention to. It can be a reference for the validation and review of PET/CT products.

         

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