放射性药物非临床安全性评价的质量保证

RADIATION PROTECTION BULLETIN ›› 2021, Vol. 41 ›› Issue (5): 36-38.

Quality Assurance for Non-clinical Safety Evaluation of Radiopharmaceuticals

Yin Jingjing, Li Mei, Liu Xiaoming, Yuan Hui, Qin Xiujun, Li Jianguo

GLP Center,China Institute for Radiation Protection,Taiyuan,Shanxi 030006

Received:2021-08-26 Online:2021-10-20 Published:2022-03-31

Abstract: Wepresent our quality assurance procedures for non-clinical safety evaluation of radiopharmaceuticals from five aspects,including laboratory management,personnel management,subject management,key test-stage inspection,and on-site inspection,to ensure the authenticity and accuracy of test data and the safety of personnel and environment.

Key words: Radiopharmaceutical, Non-clinical safety evaluation, Quality assurance

CLC Number:

R818

Cite this article

Yin Jingjing, Li Mei, Liu Xiaoming, Yuan Hui, Qin Xiujun, Li Jianguo. Quality Assurance for Non-clinical Safety Evaluation of Radiopharmaceuticals[J].RADIATION PROTECTION BULLETIN, 2021, 41(5): 36-38.

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