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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Auteurs principaux:	R. A. Volkova, O. V. Fadeikina, O. B. Ustinnikova, K. A. Sarkisyan, A. A. Movsesyants, V. A. Merkulov, V. V. Kosenko
Format:	Artigo
Langue:	Russo
Publié:	Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2024-03-01
Collection:	Биопрепараты: Профилактика, диагностика, лечение
Sujets:	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
Accès en ligne:	https://www.biopreparations.ru/jour/article/view/554
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