Specific anti-IIa activity is a key indicator of safety and efficacy in validation of biosimilarity of unfractioned heparin preparations.

Autor: Mironov AN; Research Center for Evaluation of Medical Products, the Ministry of Health of the Russian Federation, Moscow, Russia., Goryachev DV, Garvishina EV, Niyazov RR, Ivanova OY
Jazyk: angličtina
Zdroj: Bulletin of experimental biology and medicine [Bull Exp Biol Med] 2015 Feb; Vol. 158 (4), pp. 450-2. Date of Electronic Publication: 2015 Feb 24.
DOI: 10.1007/s10517-015-2782-3
Abstrakt: 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.
Databáze: MEDLINE