放射性药物非临床安全性评价的质量保证

Quality Assurance for Non-clinical Safety Evaluation of Radiopharmaceuticals

本文从五个方面介绍了放射性药物非临床安全性评价质量保证程序,包括放射性实验室管理、人员管理、受试物管理、放射性试验的现场检查和关键阶段检查,确保试验数据的真实准确以及人员与环境的安全。

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.