Сomparative Efficiency Of The Review Of Preclinical And Clinical Studies And Own Research As A Tool For Jeneric Registration

E.D. Semivelichenko(1), junior researcher, L.V. Erivanova(1), junior researcher, D.Yu. Ivkin(1), Ph.D., associate professor, head of the experimental pharmacology center, A.S. Ivkina(1), researcher, G.A. Plisko(1), junior researcher, E.I. Yeletskaya(1), junior researcher, A.S. Dzyuba(2), Ph.D., head of R & D department, A.I. Tyukavin(1), Ph.D., professor, head of the department of physiology 1-Federal State Budgetary Institution of Higher Education «St. Petersburg State University of Chemical Pharmaceuticals» of the Ministry of Health of the Russian Federation, 197376, St. Petersburg, ul. Professorа Popova, 14, lit. B 2-JSC Farmproekt, 192236, St. Petersburg, ul. Sofiyskaya, 14, lit. B E-mail: evgeniy.semivelichenko@pharminnotech.com

Abstract

To date, there are two ways to register a reproduced drug (generic) on the pharmaceutical market in terms of preclinical studies: presenting reviews of preclinical and clinical studies of the original drug or reports on the conducted preclinical studies (acute and subacute toxicity of the generic compared to the original drug). The advantage of the first method is the relative simplicity, speed and efficiency. However, only the second method allows you to fully assess the safety of the reproduced drug. Therefore, some pharmaceutical companies use both methods simultaneously. In this article, the authors analyzed and reviewed articles related to the results of preclinical and clinical studies of selective non-steroidal anti-inflammatory drug (NSAIDs) Etoricoxib, as well as the results of their own preclinical studies of the subacute (subchronic) toxicity of the original drug Arcoxia® (INN Etoricoxib) in a tablet form coated 120 mg. On the basis of their own data obtained by the authors, the authors found that the drug etoricoxib is low toxic and safe when administered repeatedly (daily for 14 days) by intragastric administration to experimental animals (rats) in doses of 10.1 mg / kg and 101.0 mg / kg (therapeutic and ten times the therapeutic dose). As a result of this study, the comparability of the results obtained by domestic and foreign researchers in the evaluation of toxicological indicators of etoricoxib with the toxicological profile of the drug, assessed by the authors of the article during the assessment of subchronic toxicity on white outbred rats of both sexes, was shown. Comparability of indicators obtained, including through the use of the authors as the test object of study of the original drug. In the case of reproduced drugs, writing reviews on preclinical and clinical trials of a reference drug seems to authors insufficient, since There are objectively high risks of introducing a drug with a nonequivalent originator of safety onto the pharmaceutical market (for example, due to a different quality of the pharmaceutical substance or other quality and / or composition of auxiliary substances).

References

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