Methodological approaches to preclinical evaluation of immunobiological serum products and their side effects

Abstract

Analysis of methodological approaches to preclinical evaluation of sensitizing activity of horse serum products shows that the anaphylactogenicity scale recommended in national regulatory documents is imperfect as it is not capable of fully predicting the safety of the clinical use of products. The article demonstrates feasibility of another methodological approach to preclinical evaluation of sensitizing activity of heterologous serum products which is based on calculation of a sensitizing dose inducing anaphylactic reactions in 50 % of guinea pigs. This approach will make it possible to more effectively predict side effects of already authorized heterologous immunoglobulins and drugs currently under development, and to select a clinical use strategy on a case-by-case basis.

Keywords

• сенсибилизирующая активность
• сывороточные иммунобиологические лекарственные препараты
• иммуноглобулины из сыворотки крови лошадей
• анафилактогенность
• методический подход
• sensitizing activity
• immunobiological serum products
• horse serum immunoglobulins
• anaphylactogenicity
• methodological approach