Current regulatory requirements for stability studies of biological medicinal products: a review

INTRODUCTION. The stability assessment of biological medicinal products (BMPs) requires special approaches and regulatory requirements. Therefore, BMPs require relevant national guidelines, which are an important prerequisite for the assurance of the safe and effective use of BMPs.AIM. This study ai...

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Bibliographic Details
Main Authors:	A. A. Soldatov, A. K. Yakovlev, Zh. I. Avdeeva, D. V. Gorenkov, A. S. Korovkin, V. V. Kosenko
Format:	Article
Language:	Russian
Published:	Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2024-10-01
Series:	Биопрепараты: Профилактика, диагностика, лечение
Subjects:	biological medicinal products biotechnological medicinal products stability studies vaccine stability accelerated stability studies stability studies under stress conditions long-term stability studies shelf life thermal stability photostability
Online Access:	https://www.biopreparations.ru/jour/article/view/613
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Current regulatory requirements for stability studies of biological medicinal products: a review

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