Method Validation for Anticomplementary Activity of Human Immunoglobulin Drugs
- Авторы: Krivykh M.1, Kornilova O.1, Bunyatyan N.1, Paramonova E.1, Volkova R.1, Fadeikina O.1
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Учреждения:
- State Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
- Выпуск: Том 50, № 9 (2016)
- Страницы: 625-629
- Раздел: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/244450
- DOI: https://doi.org/10.1007/s11094-016-1503-1
- ID: 244450
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Аннотация
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.
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Об авторах
M. Krivykh
State Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: chem@folium.ru
Россия, Moscow, 127051
O. Kornilova
State Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: chem@folium.ru
Россия, Moscow, 127051
N. Bunyatyan
State Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: chem@folium.ru
Россия, Moscow, 127051
E. Paramonova
State Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: chem@folium.ru
Россия, Moscow, 127051
R. Volkova
State Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: chem@folium.ru
Россия, Moscow, 127051
O. Fadeikina
State Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: chem@folium.ru
Россия, Moscow, 127051