Requirements for the information on reference standards submitted in the dossier for biologicals

Requirements for the information on reference standards submitted in the dossier for biologicals

SCIENTIFIC RELEVANCE. The use of appropriately certified reference standards (RSs) is a necessary element of analytical procedure standardisation that ensures comparability of results across different laboratories assessing the quality of medicines, which is important for the quality control of biol...

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Bibliographic Details
Main Authors:	R. A. Volkova, O. V. Fadeikina, O. B. Ustinnikova, K. A. Sarkisyan, A. A. Movsesyants, V. A. Merkulov, 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» 2024-03-01
Series:	Биопрепараты: Профилактика, диагностика, лечение
Subjects:	biologicals reference standard in-house reference standard biological reference materials quality control dossiers for biologicals certification of reference standards certified value expanded uncertainty stability of reference standards
Online Access:	https://www.biopreparations.ru/jour/article/view/554
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