Standardisation of the method for prekallikrein activator determination in human immunoglobulin and albumin products

Standardisation of the method for prekallikrein activator determination in human immunoglobulin and albumin products

Assessment of prekallikrein content is essential for safety control of human immunoglobulin and albumin products. The inherent variability of human prekallikrein reagents and chromogenic substrates indicates the need for standardisation of the chromogenic assay, using the components of a reference s...

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Bibliographic Details
Main Authors:	O. G. Kornilova, M. A. Krivykh, A. A. Voropaev, O. V. Fadeikina, R. A. Volkova
Format:	Article
Language:	Russian
Published:	Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2022-04-01
Series:	Биопрепараты: Профилактика, диагностика, лечение
Subjects:	human immunoglobulin and albumin products prekallikrein activator human prekallikrein standardisation reference standard certification analytical process consistency shewhart control charts
Online Access:	https://www.biopreparations.ru/jour/article/view/364

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