1. How does the Selection of Laboratory Mice Affect the Results of PhysiologicalDistribution of Radiopharmaceuticals?
- Author
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Karczmarczyk, Urszula, Ochniewicz, Piotr, Laszuk, Ewa, Tomczyk, Kamil, and Garnuszek, Piotr
- Abstract
Background: The choice of mice strain can significantly influence the physiological distributionand may lead to an inadequate assessment of the radiopharmaceutical properties. Objective: This work aims to present how the legal requirements that apply to radiopharmaceuticalscontained in the various guidelines determine the choice of the mouse strain for quality controland preclinical studies and affect the results of physiological distribution. Methods: Swiss and BALB/c mice were chosen as commonly used strains in experiments for researchand quality control purposes. Radiopharmaceuticals, i.e., preparations containing one ormore radioactive isotopes in their composition, are subject to the same legal regulations at everystage of the research, development and routine quality control as all other medicines. Therefore, invivo experiments are to be carried out to confirm the pharmacological properties and safety. Moreover,if a radiopharmaceutical's chemical structure is unknown or complex and impossible to be determinedby physicochemical methods, an analysis of physiological distribution in a rodent animalmodel needs to be performed. Results: In our studies, thirty-six mice (Swiss n=18, BALB/c n=18) were randomly divided intosix groups and injected with the following radiopharmaceuticals: [
99m Tc]Tc-Colloid, [99m Tc]Tc-DTPAand [99m Tc]Tc-EHIDA. Measurement of physiological distribution was conducted following therequirements of European Pharmacopoeia (Ph. Eur.) monograph 0689, internal instructions and theUnited States Pharmacopeia (USP) monograph. Additionally, at preclinical studies, ten mice(Swiss n=5, BALB/c n=5) were injected with the new tracer [99m Tc]Tc-PSMA-T4, and its physiologicaldistribution has been compared. The p-value <0.05 proved the statistical significance of theradiopharmaceutical physiological distribution. Conclusion: We claim that mice strain choice can significantly influence the physiological distributionand may lead to inaccurate quality control results and incomprehensible interpretation of the resultsfrom preclinical in vivo studies of a new radiopharmaceutical.- Published
- 2022
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