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

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; Shalina Raisa; Polzikov Mikhail

首页> 外文期刊>European Journal of Obstetrics, Gynecology and Reproductive Biology: An International Journal >A multicenter, randomized, phase III study comparing the efficacy and safety of follitropin alpha biosimilar and the original follitropin alpha

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

机译：多中心，随机的第三期研究比较Follitopinα生物仿制物和原始Follitopinα的疗效和安全性

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摘要

Objective: The aim of the present study was to investigate the therapeutic equivalence between the follitropin alpha biosimilar and the reference medication in women undergoing assisted reproductive technologies (ART).

机译：目的：目前研究的目的是探讨助攻生殖技术（艺术）妇女遗传素α生物酸碱物和参考药物之间的治疗当量。

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来源
《European Journal of Obstetrics, Gynecology and Reproductive Biology: An International Journal》 |2019年第2019期|共7页
作者
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; Shalina Raisa; Polzikov Mikhail;
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作者单位

AltraVita Human Reprod Clin Moscow Russia;

Mother &

Child Grp Co Perinatal Med Ctr Moscow Russia;

Mother &

Child Grp Co Perinatal Med Ctr Moscow Russia;

Mother &

Child Grp Co Perinatal Med Ctr Moscow Russia;

Mother &

Child Grp Co Lapino Clin Hosp Moscow Russia;

Mother &

Child Grp Co Lapino Clin Hosp Moscow Russia;

Mother &

Child Grp Co Lapino Clin Hosp Moscow Russia;

Mother &

Child Grp Co Lapino Clin Hosp Moscow Russia;

Mother &

Child Grp Co Lapino Clin Hosp Moscow Russia;

Mother &

Child Grp Co Lapino Clin Hosp Moscow Russia;

AltraVita Human Reprod Clin Moscow Russia;

AltraVita Human Reprod Clin Moscow Russia;

AltraVita Human Reprod Clin Moscow Russia;

Mother &

Child Grp Co Perinatal Med Ctr Moscow Russia;

AltraVita Human Reprod Clin Moscow Russia;

AltraVita Human Reprod Clin Moscow Russia;

Mother &

Child Grp Co Perinatal Med Ctr Moscow Russia;

Mother &

Child Grp Co Lapino Clin Hosp Moscow Russia;

IVFarma LLC 20 Bld 2 Moscow 117246 Russia;

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原文格式 PDF
正文语种 eng
中图分类妇产科学;
关键词
Follitropin alpha; Recombinant follicle-stimulating hormone; Biosimilar; In vitro fertilization; Assisted reproductive technology; FSH; r-hFSH;

机译：Follitopinα;重组卵泡刺激激素;生物素描;体外施肥;辅助生殖技术;FSH;R-HFSH;

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1. A multicenter, randomized, phase III study comparing the efficacy and safety of follitropin alpha biosimilar and the original follitropin alpha [J] . Barakhoeva Zarema, Vovk Lyudmila, Fetisova Yulia, European Journal of Obstetrics, Gynecology and Reproductive Biology: An International Journal . 2019,第期

机译：多中心，随机的第三期研究比较Follitopinα生物仿制物和原始Follitopinα的疗效和安全性
2. Efficacy and Safety of CKD-11101 (Proposed Biosimilar of Darbepoetin-Alfa) Compared with Darbepoetin-Alfa in Patients on Hemodialysis: A Randomized, Double-Blinded, Parallel-Group Phase III Study [J] . Kim Yaerim, Park Su-Kil, Cho Won Yong, BioDrugs: Clinical immunotherapeutics, biopharmaceuticals, and gene therapy . 2020,第1期

机译：与血液透析患者的Darbepoetin-Alfa相比，CKD-11101（Darbepoetin-Alfa的BioSimilar）的疗效和安全性：随机，双盲，平行组III研究
3. Efficacy and Safety of the Biosimilar ABP 215 Compared with Bevacizumab in Patients with Advanced Nonsquamous Non-small Cell Lung Cancer (MAPLE): A Randomized, Double-blind, Phase III Study (vol 25, pg 2088, 2019) [J] . Thatcher Nicholas, Goldschmidt Jerome H., Thomas Michael, Clinical cancer research: an official journal of the American Association for Cancer Research . 2019,第10期

机译：BioSimilar ABP的功效和安全性与先进的非小型细胞肺癌（枫木）患者（枫木）（枫木）（枫木）的患者（枫木）（枫木）：A随机，双盲，第三期研究（第25伏特25，PG 2088,2019）
4. An open-label, multicenter, randomized,comparative, safety, efficacy, cycle control,and quality of life study of CTR 25, Alesse ,and Ortho Tri-Cyclen [C] . Victoria Davis, Brian Hauck, Sheila Dunn, World Congress on Fertility and Sterility . 2004

机译：开放标签，多中心，随机，比较，安全，疗效，循环控制和CTR 25，Alesse和Ortho Tri-Cyclen的生命研究
5. BIOCHEMICAL STUDY OF POLY-ALPHA-L-GLUTAMIC ACID. PART I: THE EFFECT OF CONFORMATION ON THE CHEMICAL, PEPSIN OR PRONASE HYDROLYSIS OF POLY-ALPHA-L-GLUTAMIC ACID. PART II: BIOLOGICAL PROPERTIES OF POLY-ALPHA-L- GLUTAMIC ACID AND ITS DERIVATIVES. PART III: A NEW CALCIUM REQUIREMENT FOR THE HYDROLYSIS OF POLY-ALPHA-L-GLUTAMIC ACID BY THE CULTURE FILTRATESFROM BACILLUS LICHINOFORMIS. [D] . WAGLE, SUDHAKAR SHANTARAM. 1965

机译：聚α-L-谷氨酸的生物化学研究。第一部分：构象对聚-α-L-谷氨酸酸的化学，胃蛋白酶或蛋白酶水解的影响。第二部分：聚α-L-谷氨酸及其衍生物的生物学特性。第三部分：新的钙要求，用于培养滤液中的嗜酸芽孢杆菌（BACILLUS LICHINOFORMIS）水解聚-α-L-谷氨酸。
6. Original article: Randomised double-blind phase III study comparing the infliximab biosimilar PF-06438179/GP1111 with reference infliximab: efficacy safety and immunogenicity from week 30 to week 54 [O] . Rieke Alten, Bogdan Batko, Tomas Hala, 2019

机译：原始文章：随机双盲III期研究比较了英夫利昔单抗生物仿制药PF-06438179 / GP1111与参考英夫利昔单抗：第30周至第54周的疗效安全性和免疫原性
7. An open, randomized single-centre study to compare the efficacy and convenience of follitropin beta administered by a pen device with follitropin alpha administered by a conventional syringe in women undergoing ovarian stimulation for IVF/ICSI [O] . P. Platteau 2003

机译：开放式随机的单中心研究，用于比较用常规注射器在接受IVF / ICSI的卵巢刺激的卵巢刺激施用的卵泡装置给予氟硝蛋白β的效果和便利性

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

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