Current regulatory requirements for clinical trials of viral vaccines

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Current regulatory requirements for clinical trials of viral vaccines

Scientific relevance. In recent years, the development of various vaccines based on novel platforms has underscored the significance of updating regulatory requirements for vaccines. Consequently, clinical trials of viral vaccines need harmonised approaches within national guidelines and the Eurasia...

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Bibliographic Details
Main Authors:	A. A. Soldatov, D. V. Gorenkov, Zh. I. Avdeeva, V. A. Merkulov
Format:	Article
Language:	Russian
Published:	Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2023-12-01
Series:	Биопрепараты: Профилактика, диагностика, лечение
Subjects:	vaccines viral vaccines clinical studies clinical trials vaccine development regulatory control immune correlate of protection immunogenicity safety adverse events bridging studies
Online Access:	https://www.biopreparations.ru/jour/article/view/516
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