المؤلفون: A. N. Afanaseva, V. B. Saparova, I. E. Makarenko, T. A. Selmenskikh, D. V. Kurkin, A. L. Hohlov, R. V. Drai, А. Н. Афанасьева, В. Б. Сапарова, И. Е. Макаренко, Т. А. Сельменских, Д. В. Куркин, А. Л. Хохлов, Р. В. Драй

المساهمون: The work was carried out with the financial support of LLC "GEROPHARM". The sponsor had no influence on the course of the study or interpretation of the results., Работа выполнена при финансовой поддержке ООО «ГЕРОФАРМ». Спонсор не оказывал влияния на ход исследования и интерпретацию результатов.

المصدر: Drug development & registration; Том 13, № 1 (2024); 247-255 ; Разработка и регистрация лекарственных средств; Том 13, № 1 (2024); 247-255 ; 2658-5049 ; 2305-2066

مصطلحات موضوعية: антитела к ромиплостиму, biosimilar, neutralizing antibody studies, clinical studies of immunogenicity, validation, cell viability determination, antibodies to romiplostim, биоаналог, исследования нейтрализующих антител, клинические испытания иммуногенности, валидация, определение жизнеспособности клеток

وصف الملف: application/pdf

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Immune Thrombocytopenic Purpura. StatPearls. Treasure Island (FL): StatPearls Publishing; 2022.; Neunert C., Noroozi N., Norman G., Buchanan G. R., Goy J., Nazi I., Kelton J. G., Arnold D. M. Severe bleeding events in adults and children with primary immune thrombocytopenia: a systematic review. Journal of Thrombosis and Haemostasis. 2015;13(3):457–464. DOI:10.1111/jth.12813.; Soff G. A., Miao Y., Bendheim G., Batista J., Mones J. V., Parameswaran R., Wilkins C. R., Devlin S. M., Abou-Alfa G. K., Cercek A., Kemeny N. E., Sarasohn D. M., Mantha S. Romiplostim Treatment of Chemotherapy-Induced Thrombocytopenia. Journal of Clinical Oncology. 2019;37(31):2892–2898. DOI:10.1200/JCO.18.01931.; Bussel J. B., Soff G., Balduzzi A., Cooper N., Lawrence T., Semple J. W. A Review of Romiplostim Mechanism of Action and Clinical Applicability. Drug Design, Development and Therapy. 2021;15:2243–2268. DOI:10.2147/DDDT.S299591.; Kuter D. J. Romiplostim. In: Lyman G. H., Dale D. C., editors. Hematopoietic Growth Factors in Oncology. New York: Springer; 2011. P. 267–288. DOI:10.1007/978-1-4419-7073-2_16.; Yang A. S. Development of romiplostim: a novel engineered peptibody. Seminars in Hematology. 2015;52(1):12–15. DOI:10.1053/j.seminhematol.2014.10.007.; Bussel J.B., Kuter D. J., George J. N., McMillan R., Aledort L. M., Conklin G. T., Lichtin A. E., Lyons R. M., Nieva J., Wasser J. S., Wiznitzer I., Kelly R., Chen C.-F., Nichol J. L. AMG 531, a thrombopoiesis-stimulating protein, for chronic ITP. New England Journal of Medicine. 2006;355(16):1672–1681. DOI:10.1056/NEJMoa054626.; Kuter D. J., Bussel J. B., Lyons R. M., Pullarkat V., Gernsheimer T. B., Senecal F. M., Aledort L. M., George J. N., Kessler C. M., Sanz M. A., Liebman H. A., Slovick F. T., de Wolf J. T. M., Bourgeois E., Guthrie T. H., Newland A., Wasser J. S., Hamburg S. I., Grande C., Lefrère F., Lichtin A. E., Tarantino M. D., Terebelo H. R., Viallard J.-F., Cuevas F. J., Go R. S., Henry D. H., Redner R. 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N., Dorotenko A. R., Kalatanova A. V., Kurkin D. V., Khokhlov A. L., Drai R. V. Comparability of biosimilar romiplostim with originator: Protein characterization, animal pharmacodynamics and pharmacokinetics. Biologicals. 2023;81:101666. DOI:10.1016/j.biologicals.2023.101666.; Jawa V., Hokom M., Hu Z., El-Abaadi N., Zhuang Y., Berger D., Gupta S., Swanson S. J., Chirmule N. Assessment of immunogenicity of romiplostim in clinical studies with ITP subjects. Annals of Hematology. 2010;89(1):75–85. DOI:10.1007/s00277-010-0908-2.; Mytych D. T., Park J. K., Kim J., Barger T. E., Boshier A., Jawa V., Kuter D. J. Assessment of romiplostim immunogenicity in adult patients in clinical trials and in a global postmarketing registry. British Journal of Haematology. 2020;190(6):923–932. DOI:10.1111/bjh.16658.; Fang Q., Huang F., Liang J., Chen Y., Li C., Zhang M., Wu X., Luo W. Safety of romiplostim and eltrombopag for children with immune thrombocytopenia: a pharmacovigilance study of the FDA adverse event reporting system database. Expert Opinion on Drug Safety. 2023;22(8):707–714. DOI:10.1080/14740338.2023.2182288.; https://www.pharmjournal.ru/jour/article/view/1757

الاتاحة: https://www.pharmjournal.ru/jour/article/view/1757
https://doi.org/10.33380/2305-2066-2024-13-1-1531

المؤلفون: A. V. Babina, R. V. Drai, V. B. Saparova, A. N. Afanasyeva, P. G. Zaikin, V. I. Shmurak, T. E. Eltysheva, I. E. Makarenko, А. В. Бабина, Р. В. Драй, В. Б. Сапарова, А. Н. Афанасьева, П. Г. Заикин, В. И. Шмурак, Т. Э. Елтышева, И. Е. Макаренко

المساهمون: The sponsor of this study is LLC "GEROPHARM"., Спонсор данного исследования ООО «ГЕРОФАРМ».

المصدر: Drug development & registration; Том 12, № 2 (2023); 124-134 ; Разработка и регистрация лекарственных средств; Том 12, № 2 (2023); 124-134 ; 2658-5049 ; 2305-2066

مصطلحات موضوعية: ГИИЧ, biosimilar, genetically engineered human insulin, биоаналог, биосимиляр, генно-инженерный инсулин человека

وصف الملف: application/pdf

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الاتاحة: https://www.pharmjournal.ru/jour/article/view/1492
https://doi.org/10.33380/2305-2066-2023-12-2-124-134

المؤلفون: A. N. Afanasyeva, V. B. Saparova, I. E. Makarenko, R. V. Drai, T. A. Selmenskikh, А. Н. Афанасьева, В. Б. Сапарова, И. Е. Макаренко, Р. В. Драй, Т. А. Сельменских

المساهمون: I.S. Giba and A.A. Batueva, the authors’ colleagues from the quality assurance service of Pharm-Holding, CJSC, assisted in the research and preparation of the paper. GEROPHARM, OJSC provided funding for the research., В проведении исследования и подготовке статьи оказывали помощь коллеги из службы обеспечения качества ЗАО «Фарм Холдинг» И.С. Гиба и А.А. Батуева. Спонсорская поддержка ОАО «ГЕРОФАРМ».

المصدر: Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation; Том 13, № 1 (2023); 77-88 ; Ведомости Научного центра экспертизы средств медицинского применения. Регуляторные исследования и экспертиза лекарственных средств; Том 13, № 1 (2023); 77-88 ; 2619-1172 ; 1991-2919

مصطلحات موضوعية: инсулинозависимый захват глюкозы, L6J1 rat myogenic cell line, metabolic activity, biological activity, insulin, determination of glucose in cell culture media, insulin-dependent glucose uptake, клеточная линия миобластов крысы L6J1, метаболическая активность, биологическая активность, инсулин, определение глюкозы в клеточнойкультуральной среде

وصف الملف: application/pdf

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الاتاحة: https://www.vedomostincesmp.ru/jour/article/view/398
https://doi.org/10.30895/1991-2919-2022-398

المؤلفون: A. N. Afanasyeva, V. B. Saparova, D. D. Karal-Ogly, E. I. Mukhametzyanova, D. V. Kurkin, A. V. Kalatanova, I. E. Makarenko, A. L. Khokhlov, I. A. Lugovik, А. Н. Афанасьева, В. Б. Сапарова, Д. Д. Карал-оглы, Е. И. Мухаметзянова, Д. В. Куркин, А. В. Калатанова, И. Е. Макаренко, А. Л. Хохлов, И. А. Луговик

المساهمون: The work was carried out with the financial support of LLC GEROPHARM group. The sponsor had no influence on the choice of materials for the publication, analysis and interpretation of the data., Работа выполнена при финансовой поддержке ООО «ГЕРОФАРМ». Спонсор не оказывал влияние на выбор материала для публикации, анализ и интерпретацию данных.

المصدر: Pharmacy & Pharmacology; Том 10, № 4 (2022); 354-370 ; Фармация и фармакология; Том 10, № 4 (2022); 354-370 ; 2413-2241 ; 2307-9266 ; 10.19163/2307-9266-2022-10-4

مصطلحات موضوعية: TPO-R, biosimilar GP40141, Nplate®, complement-dependent cytotoxicity, drug safety studies, in vivo, in vitro, idiopathic thrombocytopenic purpura, toxicological profile, thrombopoietin receptor, биоаналог GP40141, Энплейт®, комплемент-зависимая цитотоксичность, исследования безопасности препаратов, идиопатическая тромбоцитопеническая пурпура, токсикологический профиль, тромбопоэтиновый рецептор

وصف الملف: application/pdf

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الاتاحة: https://www.pharmpharm.ru/jour/article/view/1165
https://doi.org/10.19163/2307-9266-2022-10-4-354-370