DOI:
10.29296/2618723X-2018-03-11
D.R. Kargopoltseva(1), K.L. Kryshen(1), M.N. Makarova(2), V.G. Makarov(1) 1-Ltd «Institute of pharmacy» Kuzmolovsky, Vsevolozhsky Dist., Leningrad Region, 3, Zavodskaya St., Build. 245, 188663, Russia; 2-RPА «Нoum оf Pharmacy» Kuzmolovsky, Vsevolozhsky Dist., Leningrad Region, 3, Zavodskaya St., Build. 245, 188663, Russia Е-mail: [email protected]
Keywords:
feed additive
preclinical and clinical studies
For citation:
Kargopoltseva D.R., Kryshen K.L., Makarova M.N., Makarov V.G. Regulatory And Methodical Aspects Of Pre-Clinical And Clinical Studies Of Feed Additives For Animals. Laboratory Animals for Science. 2018; 3. https://doi.org/10.29296/2618723X-2018-03-11
Abstract
In recent years, due to the development of agriculture and the increase in the number of pet owners, there is a rapid development of veterinary medicine not only in the Russian Federation, but throughout the world. Along with the development of veterinary medicine, there is also the improvement of veterinary pharmaceutics, which develops and produces more and more veterinary drugs and feed additives for animals. For new feed additives for animals, as well as medicines for humans, is required to pass state registration to enter the market, for which a package of documents is provided. One of the most important documents is the results of preclinical and clinical research. However, if there are many normative documents for medicines for humans in the Russian Federation that describe the scope and scheme of research, no such documents and instructions have been developed to date with feed additives. Therefore, the development of regulatory documents harmonized with international requirements is required. In this paper, the main international regulatory requirements for preclinical and clinical studies of feed additives for animals are reviewed. Based on the results of the studies, it can be concluded that this model is simple, uncomplicated and quite informative.
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