The safety of biological preparations. Part 2. Safety issues of biosimilars
The use of the reduced scheme in preclinical and clinical studies of «biosimilars» requires special attention to the safety issues. During the process of the marketing authorization of biosimilars in 2013-2015 the countries with advanced regulatory and pharmacovigilance systems (USA, Canada and EU c...
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Main Authors: | A. A. Soldatov, Zh. I. Avdeeva, Yu. V. Olefir, V. A. Merkulov, V. P. Bondarev |
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Format: | Article |
Language: | Russian |
Published: |
Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2018-02-01
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Series: | Биопрепараты: Профилактика, диагностика, лечение |
Subjects: | |
Online Access: | https://www.biopreparations.ru/jour/article/view/46 |
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