MODERN REQUIREMENTS TO THE EXPERT EVALUATION THE SPECIFIC SAFETY OF MEDICINAL PRODUCTS OF HUMAN IMMUNOGLOBULIN

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Abstract

Regulation of processes to ensure specific safety of human immunoglobulin drugs is designed to ensure the availability of eff ective and safe drugs on the Russian pharmaceutical market. Expertise within the framework of registration ensures the formation of conditions for the issuance of drugs corresponding to the level of safety. Compliance with the requirements for expert evaluation of the stages of pharmaceutical development, technological process, taking into account the control of critical stages of production, the finished form of the drug in terms of specific safety, allows to predict the degree of their negative impact on the hemostatic system, complement and kallikrein-kinin.

About the authors

O. G. Kornilova

Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation

Author for correspondence.
Email: Kornilova@expmed.ru

Ph D. Expert of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality,

Moscow

Russian Federation

E. S. Husnatdinova

Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation

Email: fake@neicon.ru

Ph D. Expert of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality,

Moscow

Russian Federation

M. A. Krivykh

Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation

Email: fake@neicon.ru

Ph D. Expert of Office of expertise allergens, cytokines and other immunomodulators of Center for Evaluation of Medicinal Immunobiological Products’ Quality,

Moscow

Russian Federation

Y. V. Olefir

Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation

Email: fake@neicon.ru

МD. General Director,

Moscow

Russian Federation

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Copyright (c) 2019 Kornilova O.G., Husnatdinova E.S., Krivykh M.A., Olefir Y.V.

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