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Journal 'Cytokines & inflammation', 2015, No. 3

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Number 3'2015

Principles of assessment of biotechnological medicines specific activity

N.A. Alpatova, Zh.I. Avdeeva, A.A. Soldatov, V.P. Bondarev, N.V. Medunitsyn

The review is devoted to studying specific biological action of biotech medicines, underlying manifestations of therapeutic effects in clinical application, and the principles of assessing the quality of medicines on a specific criterion. Biotechnological medicines produced using recombinant DNA techniques have been successfully used to treat severe autoimmune diseases, infectious diseases, cancer, and allergic diseases. This group of medicines includes medicines of cytokine system, monoclonal antibodies, medicines based on fusion proteins, and others. When studying the biological properties of the preparations at the stage of preclinical studies as well as for determining the specific biological activity when evaluating the quality of drugs, biological methods are used, reflecting the mechanism of drug action. (Cytokines and Inflammation.2015.Vol. 14. № 3.P. 10–18.).

Keywords: biotechnological medicines, specific biological activity, cytokines, monoclonal antibodies.

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