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Specific Anti-IIa Activity is a Key Indicator of Safety and Efficacy in Validation of Biosimilarity of Unfractioned Heparin Preparations

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Bulletin of Experimental Biology and Medicine Aims and scope

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.

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Authors and Affiliations

  1. Research Center for Evaluation of Medical Products, the Ministry of Health of the Russian Federation, Moscow, Russia

    A. N. Mironov, D. V. Goryachev, E. V. Garvishina, R. R. Niyazov & O. Yu. Ivanova

Authors
  1. A. N. Mironov
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  2. D. V. Goryachev
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  3. E. V. Garvishina
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  4. R. R. Niyazov
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  5. O. Yu. Ivanova
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Corresponding author

Correspondence to R. R. Niyazov.

Additional information

Translated from Byulleten’ Eksperimental’noi Biologii i Meditsiny, Vol. 158, No. 10, pp. 448-451, October, 2014

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Mironov, A.N., Goryachev, D.V., Garvishina, E.V. et al. Specific Anti-IIa Activity is a Key Indicator of Safety and Efficacy in Validation of Biosimilarity of Unfractioned Heparin Preparations. Bull Exp Biol Med 158, 450–452 (2015). https://doi.org/10.1007/s10517-015-2782-3

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  • DOI: https://doi.org/10.1007/s10517-015-2782-3

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