Studies of single-dose toxicity of radiolabeled nanoparticle Fe3O4@Lapatinib - 153Sm in animals
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Abstract
Objective: The study was conducted to evaluate single-dose toxicity of radiolabeled nanoparticles Fe3O4@Lapatinib - 153Sm produced at DaLat Nuclear Research Institute on Swiss mice. Subject and method: Radiolabeled nanoparticles Fe3O4@Lapatinib - 153Sm was injected to Swiss mice were injected the doses up to 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: The results of single-dose toxicity in Swiss mice at a dose of 20 times higher than the human dose at 24 hours after injection showed a statistically significant difference between the test group and the control group in term of biochemical, hematological and histopathological parameter. The functional recovery in the testing animals injected with radioactive nanoparticles was observed 14 days post-injection. Conclusion: The radiolabeled nanoparticles Fe3O4@Lapatinib - 153Sm has caused toxicity to organ and physiological metabolism of mice at 24 hours post-injection, however, functional recovery to normal levels was observed after 14 days. The product needs to be further studied to improve its physiochemical properties for preclinical research in the furture
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