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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