Test system for the detection of binding antibodies to interferon beta-1a for clinical use
2018
E. A. Kuzminova | T. Yu. Ostroukhova | A. V. Grachev | E. L. Morozova
Test system for determining the presence of binding antibodies to interferon beta-1a (BAB to IFN beta-1a) in serum using ELISA has been developed. The validation included sensitivity, selectivity, specificity, precision and accuracy, robustness, stability, suitability of the test system studies. The applicability of the mentioned test system has been approved for the use in clinical studies for the evaluation of interferon beta-1a immunogenicity (pegylated and non-pegylated forms).
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Биопрепараты: Профилактика, диагностика, лечение
卷
16
期
3
页码
182
- 188
ISSN
2221-996X | 2619-1156
出版者
Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
其它主题
Связывающие антитела (сат); Enzyme linked immunosorbent assay (elisa); Anti-drug antibodies (adas); Рассеянный склероз; Immunogenicity; Bioanalytical methods; Clinical studies; Иммуногенность; Клинические исследования; Интерферон бета 1а; Антитела к препарату; Биоаналитические методы исследования; Multiple sclerosis (ms); Твердофазный иммуноферментный анализ (ифа); Interferon beta-1a; Binding antibodies (bab)
语言
俄语
2024-12-12
DOAJ
