PRECLINICAL STUDY OF THE ALLERGENIC PROPERTIES OF CARBAMYLATED DARBEPOETIN

The article presents the results of a study of allergenicity of a new drug from the group of erythropoietin, carbamylated darbepoetin. The study was performed according to the Russian manual of pre-clinical studies and carried out through the following tests: the reaction of active cutaneous anaphylaxis, systemic anaphylactic reaction and delayed type reaction. The results of the reaction of active cutaneous anaphylaxis showed that the drug had caused a stain at the injection site 2.87 ± 0.17 of size, not significantly differenced from the size of the stain caused by placebo solution — 2.74 ± 0.10even tenfold dose. The systemic anaphylactic reaction has not produced any symptoms, classified according to the Weigle index. In the delayed type reaction in mice the relative size of the edema paw after administration of the shocking dose of the drug was 0.18±0.04, and did not exceed the control results — 0.16±0.03. Thus, the standard tests prove the absence of allergenic actions of carbamylated darbepoetin. Key words: carbamylated darbepoetin, allergenicity.