المؤلفون: Zh. Avdeeva I., A. Soldatov A., V. Bondarev P., V. Mosyagin D., V. Merkulov A., Ж. Авдеева И., А. Солдатов А., В. Бондарев П., В. Мосягин Д., В. Меркулов А.

المساهمون: The study reported in this publication was carried out as part of a publicity funded research project No. 056-00005-21-00 and was supported by the Scientific Centre for Expert Evaluation of Medicinal Products (R&D public accounting No. 121022000147-4)., Работа выполнена в рамках государственного задания ФГБУ «НЦЭСМП» Минздрава России № 056-00005-21-00 на проведение прикладных научных исследований (номер государственного учета НИР 121022000147-4).

المصدر: BIOpreparations. Prevention, Diagnosis, Treatment; Том 21, № 2 (2021); 97-107 ; БИОпрепараты. Профилактика, диагностика, лечение; Том 21, № 2 (2021); 97-107 ; 2619-1156 ; 2221-996X ; 10.30895/2221-996X-2021-21-2

مصطلحات موضوعية: haemophilia A, factor VIII products (plasma-derived and recombinant), immunogenicity-related safety issues, inhibitors, clinical trials, гемофилия А, препараты фактора VIII (препараты плазмы крови и рекомбинантные), проблемы безопасности, связанные с иммуногенностью, ингибиторы, клинические исследования

وصف الملف: application/pdf

Relation: https://www.biopreparations.ru/jour/article/view/314/423; https://www.biopreparations.ru/jour/article/downloadSuppFile/314/234; https://www.biopreparations.ru/jour/article/downloadSuppFile/314/235; https://www.biopreparations.ru/jour/article/downloadSuppFile/314/236; Волкова СА, Боровков НН. Основы клинической гематологии. Учебное пособие. Н. Новгород: НижГМА; 2013.; Бломбек М, Антович Й, ред. Нарушения свертывания крови. Практические рекомендации по диагностике и лечению. М.: Медицинская литература; 2014.; Зозуля НИ, Свирин ПВ. Диагностика и лечение гемофилии. Национальные клинические рекомендации. М.: Национальное гематологическое общество; 2014.; Сараева НО. Гематология. Учебное пособие. Изд. 2-е, перераб. Иркутск: ИГМУ; 2015.; Орлова НА, Ковнир СВ, Воробьев ИИ, Габибов АГ, Воробьев АИ. Фактор свертывания крови VIII — от эволюции к терапии. Acta Naturae. 2013;5(2):19–39.; Зозуля НИ, Чернов МВ, Тарасова ИС, Румянцев АГ. Нерешенные вопросы оказания медицинской помощи пациентам с ингибиторной формой гемофилии. Российский журнал детской гематологии и онкологии. 2019;6(2):48–53. https://doi.org/10.21682/2311-1267-2019-6-2-48-53; Mannucci PM, Tuddenham EG. The hemophilias — from royal genes to gene therapy. N Engl J Med. 2001;344(23):1773–9. https://doi.org/10.1056/NEJM200106073442307; Colman RW, Hirsh J, Marder VJ, Clowes AW, George JN, eds. Hemostasis and Thrombosis. Basic Principles and Clinical Practice. 4th ed. Philadelphia: Lippincott Williams Wilkins; 2001.; DeLoughery TG. Hemophilia. In: DeLoughery TG, ed. Hemostasis and thrombosis. 2nd ed. Springer; 2019. P. 23–31. https://doi.org/10.1007/978-3-030-19330-0_4; Авдеева ЖИ, Солдатов АА, Бондарев ВП, Мосягин ВД, Меркулов ВА. Лекарственные препараты фактора VIII, актуальные вопросы разработки, клинического исследования и применения (часть 1). БИОпрепараты. 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Treatment characteristics and the risk of inhibitor development: a multicenter cohort study among previously untreated patients with severe hemophilia A. J Thromb Haemost. 2007;5(7):1383–90. https://doi.org/10.1111/j.1538-7836.2007.02595.x; Matzinger P. Friendly and dangerous signals: is the tissue in control? Nat Immunol. 2007;8(1):11–3. https://doi.org/10.1038/ni0107-11; Kurnik K, Bidlingmaier C, Engl W, Chehadeh H, Reipert B, Auerswald G. New early prophylaxis regimen that avoids immunological danger signals can reduce FVIII inhibitor development. Haemophilia. 2010;16(2):256–62. https://doi.org/10.1111/j.1365-2516.2009.02122.x; Gouw SC, van den Berg HM, Fischer K, Auerswald G, Carcao M, Chalmers E, et al. Intensity of factor VIII treatment and inhibitor development in children with severe hemophilia A: the RODIN study. Blood. 2013;121(20):4046–55. https://doi.org/10.1182/blood-2012-09-457036; van Velzen AS, Eckhardt CL, Peters M, Leebeek FWG, Escuriola-Ettingshausen C, Hermans C, et al. Intensity of factor VIII treatment and the development of inhibitors in non-severe hemophilia A patients: results of the INSIGHT case-control study. J Thromb Haemost. 2017;15(7):1422–9. https://doi.org/10.1111/jth.13711; Iorio A, Halimeh S, Holzhauer S, Goldenberg N, Marchesini E, Marcucci M, et al. Rate of inhibitor development in previously untreated hemophilia A patients treated with plasma-derived or recombinant factor VIII concentrates: a systematic review. J Thromb Haemost. 2010;8(6):1256–65. https://doi.org/10.1111/j.1538-7836.2010.03823.x; Lacroix-Desmazes S, Repess é Y, Kaveri SV, Dasgupta S. The role of VWF in the immunogenicity of FVIII. Thromb Res. 2008;122(Suppl 2):S3–6. https://doi.org/10.1016/S0049-3848(08)70002-1; Oldenburg J, Lacroix-Desmazes S, Lillicrap D. Alloantibodies to therapeutic factor VIII in hemophilia A: the role of von Willebrand factor in regulating factor VIII immunogenicity. Haematologica. 2015;100(2):149–56. https://doi.org/10.3324/haematol.2014.112821; Fulcher CA, de Graaf Mahoney S, Zimmerman TS. FVIII inhibitor IgG subclass and FVIII polypeptide speci fi city determined by immunoblotting. Blood. 1987;69(5):1475–80.; Reding MT, Lei S, Lei H, Green D, Gill J, Conti-Fine BM. Distribution of Th1- and Th2-induced anti-factor VIII IgG subclasses in congenital and acquired hemophilia patients. Thromb Haemost. 2002;88(4):568–75.; van Helden PMW, van den Berg HM, Gouw SC, Kaijen PHP, Zuurveld MG, Mauser-Bunschoten EP, et al. IgG subclasses of anti-FVIII antibodies during immune tolerance induction in patients with hemophilia A. Br J Haematol. 2008;14(4)2:644–52. https://doi.org/10.1111/j.1365-2141.2008.07232.x; Prescott R, Nakai H, Saenko EL, Scharrer I, Nilsson IM, Humphries JE, et al. The inhibitor antibody response is more complex in hemophilia A patients than in most nonhemophiliacs with factor VIII autoantibodies. Recombinate and Kogenate Study Groups. Blood. 1997;89(10):3663–71.; Fijnvandraat K, Celie PH, Turenhout EA, ten Cate JW, van Mourik JA, Mertens K, et al. A human alloantibody interferes with binding of factor IXa to the factor VIII light chain. Blood. 1998;91(7):2347–52.; Fay PJ, Scandella D. Human inhibitor antibodies specific for the FVIII A2 domain disrupt the interaction between the subunit and factor IXa. J Biol Chem. 1999;274(42):29826–30. https://doi.org/10.1074/jbc.274.42.29826; Arai M, Scandella D, Hoyer LW. Molecular basis of factor VIII inhibition by human antibodies. Antibodies that bind to the factor VIII light chain prevent the interaction of factor VIII with phospholipid. J Clin Invest. 1989;83(6):1978–84. https://doi.org/10.1172/JCI114107; Zhong D, Saenko EL, Shima M, Felch M, Scandella D. Some human inhibitor antibodies interfere with factor VIII binding to factor IX. Blood. 1998;92(1):136–42.; Nogami K, Shima M, Nishiya K, Sakurai Y, Tanaka I, Gidding JC, et al. Human factor VIII inhibitor alloantibodies with a C2 epitope inhibit factor Xa-catalyzed factor VIII activation: a new anti-FVIII inhibitory mechanism. Thromb Haemost. 2002;87(3):459–65.; Meeks SL, Healey JF, Parker ET, Barrow RT, Lollar P. Non-classical anti-C2 domain antibodies are present in patients with factor VIII inhibitors. Blood. 2008;112(4):1151–3. https://doi.org/10.1182/blood-2008-01-132639; Astermark J, Voorberg J, Lenk H, DiMichele D, Shapiro A, Tjönnfjord G, Berntorp E. Impact of inhibitor epitope profile on the neutralizing effect against plasma-derived and recombinant factor VIII concentrates in vitro. Haemophilia. 2003;9(5):567–72. https://doi.org/10.1046/j.1365-2516.2003.00802.x; Gharagozlou S, Sharifian RA, Khoshnoodi J, Karimi K, Milani M, Okita DK, et al. 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الاتاحة: https://www.biopreparations.ru/jour/article/view/314
https://doi.org/10.30895/2221-996X-2021-21-2-97-107

المؤلفون: A. Soldatov A., Zh. Avdeeva I., V. Bondarev P., V. Merkulov A., V. Mosyagin D., V. Ivanov B., D. Gorenkov V., L. Khantimirova M., А. Солдатов А., Ж. Авдеева И., В. Бондарев П., В. Меркулов А., В. Мосягин Д., В. Иванов Б., Д. Горенков В., Л. Хантимирова М.

المساهمون: The study reported in this publication was carried out as part of a publicity funded research project No. 056-00003-20-00 and was supported by the Scientific Centre for Expert Evaluation of Medicinal Products (R&D public accounting No. AAAA-A18-118021590046-9)., Работа выполнена в рамках государственного задания ФГБУ «НЦЭСМП» Минздрава России № 056-00003-20-00 на проведение прикладных научных исследований (номер государственного учета НИР AAAA-A18-118021590046-9).

المصدر: BIOpreparations. Prevention, Diagnosis, Treatment; Том 20, № 4 (2020); 228-244 ; БИОпрепараты. Профилактика, диагностика, лечение; Том 20, № 4 (2020); 228-244 ; 2619-1156 ; 2221-996X ; 10.30895/2221-996X-2020-20-4

مصطلحات موضوعية: COVID-19 pandemic, vaccines, SARS-CoV-2 virus, regulatory requirements, fast-track approval of vaccines, COVID-19 vaccine authorisation, пандемия COVID-19, вакцины, вирус SARS-CoV-2, нормативные требования, ускоренная регистрация вакцин, регистрация вакцин против COVID-19

وصف الملف: application/pdf

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Evaluation of antihemagglutinin and antineuraminidase antibodies as correlates of protection in an influenza A/H1N1 virus healthy human challenge model. mBio. 2016;7(2):e00417-16. https://doi.org/10.1128/mbio.00417-16; Verity R, Okell LC, Dorigatti I, Winskill P, Whittaker C, Imai N, et al. Estimates of the severity of coronavirus disease 2019: a model-based analysis. Lancet Infect Dis. 2020;20(6):669– 77. https://doi.org/10.1016/s1473-3099(20)30243-7; Palacios R, Shah SK. When could human challenge trials be deployed to combat emerging infectious diseases? Lessons from the case of a Zika virus human challenge trial. Trials. 2019;20(Suppl 2):702. https://doi.org/10.1186/s13063-019-3843-0; Shah SK, Kimmelman J, Lyerly AD, Lynch HF, McCutchan F, Miller FG, et al. Ethical considerations for Zika virus human challenge trials. National Institute of Allergy and Infectious Diseases; 2017.; Nieman AE, de Mast Q, Roestenberg M, Wiersma J, Pop G, Stalenhoef A, et al. 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Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia. Lancet. 2020;396(10255):887– 97. https://doi.org/10.1016/s0140-6736(20)31866-3; Zhu FC, Li YH, Guan XH, Hou LH, Wang WJ, Li JX, et al. Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a doseescalation, open-label, non-randomised, first-in-human trial. Lancet. 2020;395(10240):1845–54. https://doi.org/10.1016/s0140-6736(20)31208-3; Folegatti PM, Ewer KJ, Aley PK, Angus B, Becker S, BelijRammerstorfer S, et al. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. Lancet. 2020;396(10249):467–78. https://doi.org/10.1016/s0140-6736(20)31604-4; Jackson LA, Anderson EJ, Rouphael NG, Roberts PC, Makhene M, Coler RN, et al. An mRNA vaccine against SARS-CoV-2 — preliminary report. N Engl J Med. 2020;NEJMoa2022483. https://doi.org/10.1056/nejmoa2022483 [Epub ahead of print]; Zhu FC, Hou LH, Li JX, Wu SP, Liu P, Zhang GR, et al. Safety and immunogenicity of a novel recombinant adenovirus type-5 vector-based Ebola vaccine in healthy adults in China: preliminary report of a randomised, double-blind, placebocontrolled, phase 1 trial. Lancet. 2015;385(9984):2272–9. https://doi.org/10.1016/s0140-6736(15)60553-0; https://www.biopreparations.ru/jour/article/view/311

الاتاحة: https://www.biopreparations.ru/jour/article/view/311
https://doi.org/10.30895/2221-996X-2020-20-4-228-244

المؤلفون: Zh. Avdeeva I., A. Soldatov A., N. Alpatova A., V. Bondarev P., Yu. Olefir V., V. Merkulov A., V. Mosyagin D., N. Medunitsyn V., Ж. Авдеева И., А. Солдатов А., Н. Алпатова А., В. Бондарев П., Ю. Олефир В., В. Меркулов А., В. Мосягин Д., Н. Медуницын В.

المصدر: BIOpreparations. Prevention, Diagnosis, Treatment; Том 16, № 4 (2016); 208-218 ; БИОпрепараты. Профилактика, диагностика, лечение; Том 16, № 4 (2016); 208-218 ; 2619-1156 ; 2221-996X ; undefined

مصطلحات موضوعية: биоподобные/биоаналоговые («biosimilars») препараты, лекарственные препараты моноклональных антител, оценка качества, доклинические исследования, клинические исследования, biosimilar products, monoclonal antibody products, quality assessment, preclinical trials, clinical trials

وصف الملف: application/pdf

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