Method Validation for Anticomplementary Activity of Human Immunoglobulin Drugs
- Авторлар: Krivykh M.1, Kornilova O.1, Bunyatyan N.1, Paramonova E.1, Volkova R.1, Fadeikina O.1
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Мекемелер:
- State Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
- Шығарылым: Том 50, № 9 (2016)
- Беттер: 625-629
- Бөлім: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/244450
- DOI: https://doi.org/10.1007/s11094-016-1503-1
- ID: 244450
Дәйексөз келтіру
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.
Негізгі сөздер
Авторлар туралы
M. Krivykh
State Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: chem@folium.ru
Ресей, 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
Ресей, 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
Ресей, 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
Ресей, 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
Ресей, 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
Ресей, Moscow, 127051