Physicochemical Properties, Toxicity, and Specific Activity of a Follitropin Alpha Biosimilar
| Autor: | M. V. Serebryakova, B. S. Mel’nik, Yu. A. Khodak, A. I. Gosudarev, M. A. Polzikov, A. S. Semikhin, D. V. Byrikhina, M. S. Krasil’shchikova, I. I. Vorob’ev, O. V. Proskurina |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Pharmacology Glycan 030219 obstetrics & reproductive medicine biology Chemistry Biological activity Bioequivalence law.invention 03 medical and health sciences 030104 developmental biology 0302 clinical medicine law In vivo Pharmacodynamics Drug Discovery Toxicity Recombinant DNA biology.protein Specific activity |
| Zdroj: | Pharmaceutical Chemistry Journal. 50:753-760 |
| ISSN: | 1573-9031 0091-150X |
| Popis: | Comparative analysis of the primary structure of recombinant human follicle-stimulating hormone (r-hFSH) in samples of follitropin alpha biosimilar (FAB) preparation and the reference drug Gonal-F showed they were identical while spectral analysis of their secondary and tertiary structures indicated they were bioequivalent. Analytical results for N-glycans and sialic acids revealed that the main glycan structures were similar and the distributions of the main forms of sialic acids in the compared samples differed insignificantly. Results of in vitro and in vivo biological activity testing confirmed that FAB and Gonal-F were equivalent with respect to WHO standards. Comparative testing of the acute and subacute toxicity did not reveal significant differences between the two drugs and also confirmed they were identical. Thus, the investigation proved that FAB and the reference drug were equivalent with respect to the main physicochemical, pharmacodynamic, and toxicological characteristics. |
| Databáze: | OpenAIRE |
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