A multicenter, randomized, phase III study comparing the efficacy and safety of follitropin alpha biosimilar and the original follitropin alpha

Author:

Barakhoeva Zarema,Vovk Lyudmila,Fetisova Yulia,Marilova Nina,Ovchinnikova Maria,Tischenko Marina,Scherbatyuk Yulia,Kolotovkina Alexandra,Miskun Anna,Kasyanova Galina,Teterina Tatyana,Zorina Irina,Belousova Nadezhda,Morozova Ekaterina,Yakovenko Sergey,Apryshko Valentina,Sichinava Lali,Shalinа Raisa,Polzikov MikhailORCID

Funder

IVFarma LLC

Publisher

Elsevier BV

Subject

Obstetrics and Gynaecology,Reproductive Medicine

Reference29 articles.

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2. Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle stimulating hormone (r-hFSH);Committee for Medicinal Products for Human Use;EMA,2012

3. Physicochemical properties, toxicity, and specific activity of a follitropin alpha biosimilar;Vorob’ev;Pharm Chem J,2017

4. High-level expression of biologically active human follicle stimulating hormone in the Chinese hamster ovary cell line by a pair of tricistronic and monocistronic vectors;Orlova;PLoS One,2019

5. Randomized crossover comparative study of safety, tolerance and pharmacokinetics of primapur vs. Gonal-f upon single-dose subcutaneous administration in healthy volunteers;Tyul’kina;Eksperimental’naya i Klinicheskaya Farmakologiya,2017

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