Potency evaluation of erythropoietin products: current status

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Potency evaluation of erythropoietin products: current status

INTRODUCTION. Given the widespread clinical use of recombinant human erythropoietin (rhEPO) products from different manufacturers, potency assays should ensure that patients receive comparable doses of rhEPO across medicinal products. The harmonisation of approaches to potency testing requires the u...

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Bibliographic Details
Main Authors:	L. A. Gaiderova, N. A. Alpatova, S. L. Lysikova, A. M. Guskov, O. V. Golovinskaya
Format:	Article
Language:	Russian
Published:	Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2024-12-01
Series:	Биопрепараты: Профилактика, диагностика, лечение
Subjects:	erythropoietins recombinant human erythropoietin rhepo epoetin darbepoetin potency pharmacopoeial requirements <i>in vivo</i> assay <i>in vitro</i> assay reference standard 3r principle
Online Access:	https://www.biopreparations.ru/jour/article/view/614
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