Consideration on Animal Experiment in PET/CT.
10.3969/j.issn.1671-7104.2022.04.021
- Author:
Xiaofang GU
1
;
Yaqing BAO
1
;
Liping HE
1
Author Information
1. Center for Medical Device Evaluation, NMPA, Beijing, 100081.
- Publication Type:Journal Article
- Keywords:
PET;
PET/CT;
animal experiment;
product review;
product validation
- MeSH:
Animal Experimentation;
Animals;
Positron Emission Tomography Computed Tomography;
Positron-Emission Tomography;
Tomography, X-Ray Computed
- From:
Chinese Journal of Medical Instrumentation
2022;46(4):454-458
- CountryChina
- Language:Chinese
-
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.
