Method Validation for Anticomplementary Activity of Human Immunoglobulin Drugs

M. A. Krivykh; O. G. Kornilova; N. D. Bunyatyan; E. V. Paramonova; R. A. Volkova; O. V. Fadeikina

doi:10.1007/s11094-016-1503-1

Method Validation for Anticomplementary Activity of Human Immunoglobulin Drugs

作者: Krivykh M.A.¹, Kornilova O.G.¹, Bunyatyan N.D.¹, Paramonova E.V.¹, Volkova R.A.¹, Fadeikina O.V.¹
隶属关系:
1. State Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
期: 卷 50, 编号 9 (2016)
页面: 625-629
栏目: Article
URL: https://ogarev-online.ru/0091-150X/article/view/244450
DOI: https://doi.org/10.1007/s11094-016-1503-1
ID: 244450

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详细

Amethod for determining anticomplementary activity of human immunoglobulin (Ig) preparations for i.v. administration by complement fixation test was validated for accuracy, precision (repeatability, intralaboratory precision), limit of quantitation (LOQ), linearity, and analytical domain. The method could be used for quality assessment using the “anticomplementary activity” as part of the pharmaceutical quality examination of human Ig preparations.