Kushnir I. Pharmacotoxicological evaluation of veterinary medical products in terms of biological safety indexes

Test subject: pharmacotoxycological assessment of biological safety indices of veterinary medicinal drugs and system of their control. Objective research: develop and implement in practice of veterinary medicine of Ukraine scientifically grounded system pharmaco-toxicological assessment of sterile and not- sterile medical forms of veterinary drugs in terms of biological safety. Test methods: pharmacotoxicological, hematological, histological, microbiological, instrumental (optical) and statistically mathematical ones. Scientific innovation: proposed well-grounded complex scientific system of pharmatoxycological assessment of veterinary medicinal drugs according to biological safety indices that includes conducting of pharmacopoeia control methods, determination of biological safety indices for sterile and non-sterile forms of medicinal products according to requirements of national and international standards. The tests of bacterial endotoxin determination in medicinal products for parenteral administration were conducted and their stability was determined. Pharmacopoeia methods of antimicrobial action determination of non-sterile forms of medicinal products and methods of their elimination were developed. The influence of polyethylene oxides on pharmacological peculiarities of antimicrobial medicinal products were examined and complex assessment of biological safety indices of non-sterile forms of medicinal products were conducted. Degree of implementation: on the basis of test results SOU 85.20-37-391:2006 "Veterinary medicinal products. Methods of harmlessness determination" and SOU 85.20-37-00485670-927:2012 "Veterinary medicinal products. Parameters of microbiological purity of non-sterile drug forms" that are used under control of veterinary medicinal products on enterprises of Ukraine. Manufacture proposals laid out in methodic recommendations: "Rules of test organization of sterile veterinary medicinal drugs", "Sample selection norms and number of veterinary medicinal drugs needed for determination of sterility", "Determination of bacterial endotoxins in solutions for injections by means of gelation method: marginal test". Application field: veterinary medicine.