Отправить статью по E-mail Harmonization of Activity Determination Requirements for Recombinant Blood Clotting Factor rFVIIa
- Авторы: Ustinnikova O.B.1,2, Novikova E.V.1, Runova O.B.1, Shvedov D.V.1, Zhilyaeva M.V.3, Kudlai D.A.2
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Учреждения:
- Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
- Generium Inc.
- Generium International Biotechnology Center
- Выпуск: Том 51, № 6 (2017)
- Страницы: 500-503
- Раздел: Structure of Chemical Compounds, Methods of Analysis and Process Control
- URL: https://ogarev-online.ru/0091-150X/article/view/244676
- DOI: https://doi.org/10.1007/s11094-017-1642-z
- ID: 244676
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Аннотация
The interchangeability of coagulation methods for determining the activity of recombinant blood clotting factor rFVIIa was assessed. Single-factor analysis of variance (ANOVA) and comparison of the metrological characteristics of the methods led to the conclusion that results obtained by reproducing the methods of the European Pharmacopoeia and Generium were comparable and interchangeable. One method could be used to confirm that a drug conformed to regulations established using another method. The Generium method was chosen for introduction into national pharmacopoeial practice because it was more economical.
Об авторах
O. Ustinnikova
Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation; Generium Inc.
Автор, ответственный за переписку.
Email: Ustinnikova@expmed.ru
Россия, 8/2 Petrovskii Blvd., Moscow, 127051; Moscow
E. Novikova
Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: Ustinnikova@expmed.ru
Россия, 8/2 Petrovskii Blvd., Moscow, 127051
O. Runova
Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: Ustinnikova@expmed.ru
Россия, 8/2 Petrovskii Blvd., Moscow, 127051
D. Shvedov
Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: Ustinnikova@expmed.ru
Россия, 8/2 Petrovskii Blvd., Moscow, 127051
M. Zhilyaeva
Generium International Biotechnology Center
Email: Ustinnikova@expmed.ru
Россия, Moscow, 123317
D. Kudlai
Generium Inc.
Email: Ustinnikova@expmed.ru
Россия, Moscow
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