caa a22 4500 605538190 CHVBK 20210128100901.0 cr unu---uuuuu 210128e20150201xx s 000 0 eng 10.1007/s10517-015-2782-3 doi (NATIONALLICENCE)springer-10.1007/s10517-015-2782-3 Specific Anti-IIa Activity is a Key Indicator of Safety and Efficacy in Validation of Biosimilarity of Unfractioned Heparin Preparations [Elektronische Daten] [A. Mironov, D. Goryachev, E. Garvishina, R. Niyazov, O. Ivanova] We compared anti-IIa activity of a heparin analogue and a reference product was carried out to confirm their biosimilarity. The experiment was based on the method of estimation of anti-IIa activity of a commercial sodium heparin preparation according to United States Pharmacopoeia. High similarity of the two medicinal heparin preparations by this parameter is shown. The method is recommended for the use in comparability studies. Springer Science+Business Media New York, 2015 unfractioned heparin nationallicence quantitave estimation of activity nationallicence anti-IIa activity nationallicence Mironov A. Research Center for Evaluation of Medical Products, the Ministry of Health of the Russian Federation, Moscow, Russia aut Goryachev D. Research Center for Evaluation of Medical Products, the Ministry of Health of the Russian Federation, Moscow, Russia aut Garvishina E. Research Center for Evaluation of Medical Products, the Ministry of Health of the Russian Federation, Moscow, Russia aut Niyazov R. Research Center for Evaluation of Medical Products, the Ministry of Health of the Russian Federation, Moscow, Russia aut Ivanova O. Research Center for Evaluation of Medical Products, the Ministry of Health of the Russian Federation, Moscow, Russia aut Bulletin of Experimental Biology and Medicine Springer US; http://www.springer-ny.com 158/4(2015-02-01), 450-452 0007-4888 158:4<450 2015 158 10517 https://doi.org/10.1007/s10517-015-2782-3 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s10517-015-2782-3 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Mironov A. Research Center for Evaluation of Medical Products, the Ministry of Health of the Russian Federation, Moscow, Russia aut NATIONALLICENCE 700 1- Goryachev D. Research Center for Evaluation of Medical Products, the Ministry of Health of the Russian Federation, Moscow, Russia aut NATIONALLICENCE 700 1- Garvishina E. Research Center for Evaluation of Medical Products, the Ministry of Health of the Russian Federation, Moscow, Russia aut NATIONALLICENCE 700 1- Niyazov R. Research Center for Evaluation of Medical Products, the Ministry of Health of the Russian Federation, Moscow, Russia aut NATIONALLICENCE 700 1- Ivanova O. Research Center for Evaluation of Medical Products, the Ministry of Health of the Russian Federation, Moscow, Russia aut NATIONALLICENCE 773 0- Bulletin of Experimental Biology and Medicine Springer US; http://www.springer-ny.com 158/4(2015-02-01), 450-452 0007-4888 158:4<450 2015 158 10517