ISSN: 1859 - 2872
Single dose toxicity of radiopharmaceutical [18F]-fluorothymidine in mice
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Abstract
Objective: To evaluate the single dose toxicity of radiopharmaceutical 18F-FLT prepared on an in-house synthesis module designed and installed at the Cyclotron Center, 108 Military Central Hospital. Subject and method: 18F-FLT was produced at the Cyclotron Center and the quality followed the monograph of European Pharmacopeia. The animals were Swiss mice, and the injected doses were 100 times higher than the equivalent human dose according to the European Medicines Agency (EMA) guidelines for single-dose toxicity testing method for microdoses of active ingredients and OECD guidelines for acute toxicity studies. Result: After 14 days and 24 hours of radiopharmaceutical injection with the dose of 20mCi per kilogram of weight. The results of hematology and biochemistry tests, weight measuring of the testing groups were not statistically significant when compared to the control groups injected with saline 0.9%. Some percentages of relative organ weight present the significant difference, however, the results of histology and pathology of kidneys and livers from the two mice groups showed no abnormality. Conclusion: The radiopharmaceutical 18F-FLT produced by the in-house module in the Cyclotron Center at 108 Military Central Hospital had no single dose toxicity in the mice model
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References
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