IMMUNOGENICITY AND SAFETY OF BIOTECHNOLOGICAL MEDICINES
- 作者: Soldatov A.1, Avdeeva Z.1, Bondarev V.1, Merkylov V.1
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隶属关系:
- Scientific Centre for Expert Evaluation of Medicinal Products
- 期: 卷 22, 编号 2-1 (2019)
- 页面: 557-559
- 栏目: ORIGINAL ARTICLES
- URL: https://journals.rcsi.science/1028-7221/article/view/120300
- DOI: https://doi.org/10.31857/S102872210006972-4
- ID: 120300
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The efficacy and safety of the use of biotechnological (biotherapeutic, genetic engineering) preparations are due to their targeted mechanism of action and low of toxicity, in contrast to traditional chemicals drugs. These features of biotherapeutic preparations also aff ect their safety profile. When treating with biotherapeutic preparations, the most major adverse reaction and the first developmental time is the so-called infusion reaction. The basis of the development of the reaction to the infusion of a biotherapeutic preparation may be one of the following reactions: cytokine release syndrome (CRS), type I hypersensitivity reaction (IgE-dependent allergic reaction) or IgG-mediated reaction. These reactions have a similar clinical picture, so it is difficult to clearly determine which mechanisms led to the development of the reaction to the infusion. The mechanisms of development of the reaction to the infusion are still poorly studied.
作者简介
A. Soldatov
Scientific Centre for Expert Evaluation of Medicinal Products
编辑信件的主要联系方式.
Email: Patosold@mail.ru
DM, Chief Expert of Office of expertise allergens, cytokines and other immunomodulators of Center for examination and control of medical immunobiological preparations,
Moscow
俄罗斯联邦Zh. Avdeeva
Scientific Centre for Expert Evaluation of Medicinal Products
Email: fake@neicon.ru
DM, professor, Chief Expert of Office of expertise allergens, cytokines and other immunomodulators of Center for examination and control of medical immunobiological preparations,
Moscow
俄罗斯联邦V. Bondarev
Scientific Centre for Expert Evaluation of Medicinal Products
Email: fake@neicon.ru
DM, professor, Director of Centre of expertise of the medical immunobiological preparations quality,
Moscow
俄罗斯联邦V. Merkylov
Scientific Centre for Expert Evaluation of Medicinal Products
Email: fake@neicon.ru
DM, professor, Deputy Director General for the expertise of drugs of Center for examination and control of medical immunobiological preparations,
Moscow
俄罗斯联邦参考
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