PRECLINICAL STUDY OF THE DNA-DAMAGING ACTIVITY AND GENOTOXICITY OF CARBAMYLATED DARBEPOETIN

The article presents the results of a potential mutagenicity studying of a new drug from the group of erythropoietin, carbamylateddarbepoetin. The study was performed using DNA-comet assay in mice, and in micronucleus test. As a positive control there were used mice which had been injected with genotoxicantmethylmethane sulfonate at a dose of 40 mg/kg and as a negative control there were mice after administration of equivalent doses of a placebo. The results showed that the mutagenic effect of the drug in single (3.59±1.02) dosing and three times (4.0±0.78) dosing had not been different from the mutagenic effect of placebo (4.39±1.34). Micronucleus test was performed using a cytogenetic damage of bone marrow cells and checking the appearance of polychromatophil cells, containing micronuclei. It was established that carbamylateddarbepoetin within stated doses according to the used test, has no a potential carcinogenic effect. Key words: DNA-comet assay, mutagenicity, carbamylateddarbepoetin, cytogenetic damage.