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1Academic Journal
Source: Фармакокинетика и Фармакодинамика, Vol 0, Iss 1, Pp 12-15 (2014)
Subject Terms: биосимиляр, биотехнология, биоаналог, подобный биологический лекарственный продукт, дженерики, biosimilar, biotechnology, bioanalogue, similar biological medicinal product, generic, Pharmacy and materia medica, RS1-441
File Description: electronic resource
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2Academic Journal
Authors: ЕЛЬЦОВА Е.А., РАМЕНСКАЯ Г.В., СМОЛЯРЧУК Е.А., БУШМАНОВА А.В.
Subject Terms: БИОСИМИЛЯР, БИОТЕХНОЛОГИЯ, БИОАНАЛОГ, ПОДОБНЫЙ БИОЛОГИЧЕСКИЙ ЛЕКАРСТВЕННЫЙ ПРОДУКТ, ДЖЕНЕРИКИ
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3Academic Journal
Authors: E. A. Eltcova, G. V. Ramenskaya, E. A. Smolyarchuk, A. V. Bushmanova, Е. А. Ельцова, Г. В. Раменская, Е. А. Смолярчук, А. В. Бушманова
Source: Pharmacokinetics and Pharmacodynamics; № 1 (2015); 12-15 ; Фармакокинетика и Фармакодинамика; № 1 (2015); 12-15 ; 2686-8830 ; 2587-7836
Subject Terms: generic, биотехнология, биоаналог, подобный биологический лекарственный продукт, дженерики, biosimilar, biotechnology, bioanalogue, similar biological medicinal product
File Description: application/pdf
Relation: https://www.pharmacokinetica.ru/jour/article/view/148/148; На мировом фармрынке доминируют биопрепараты URL:http://www.pharmvestnik.ru/publs/lenta/obzory/na-mirovom-farmrynke-domimrujut-biopreparaty.html#.U0wwBFV_tc0.; Об обращении лекарственных средств [Электронный ресурс]: Федеральный закон от 12.04.2010 N 61-ФЗ (ред. от 12.03.2014). Доступ из справ.-правовой системы «Консультант Плюс».; Проект Федерального закона от 21.01.2013 г. «О внесении изменений в Федеральный закон «Об обращении лекарственных средств» и в статью 333.32.1. части второй Налогового кодекса Российской Федерации».; Biosimilars: a overview. http://www.researchgate.net/publication/228730641_Biosimilars_an_overview.; Annex to Guideline on Similar Biological Medicinal Products Containing Biotechnology derived Proteins as Drug Substance -Non Clinical and Clinical Issues containing Recombinant Granulocyte Colony-Stimulating Factor, CHMP/31329/05, February 2006. URL: www.ema.europa. eu/pdfs/human/biosimilar/3132905en; Annex to Guideline on Similar Biological Medicinal Products Containing Biotechnology derived Proteins as Drug Substance - Non Clinical and Clinical Issues containing Recombinant Human Erythropoietin, CHMP/94526/05, March 2006. URL: www.ema.europa.eu/pdfs/human/ biosimilar/9452605en. Accessed 02 September 2010.; Annex to Guideline on Similar Biological Medicinal Products Containing Biotechnology derived Proteins as Drug Substance- Non Clinical and Clinical Issues containing Recombinant Human Growth Hormone, CHMP/94528/05, February 2006. URL: www.ema.europa.eu/pdfs/human/ biosimilar/9452805en.; Guideline on Immunogenicity Assessment of Biotechnology-derived Therapeutic Proteins. EMEA/CHMP/BMWP/14327/2006, December 2007. URL:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003946.pdf.; Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues EMEA/CHMP/BMWP/32775/2005_Rev., December 2012. URL:http://www.ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2012/12/WC500136392.pdf.; Guideline on Similar Biological MedicinalProducts, CPMP/437/04, October 2005. URL:http://www.ema.europa.eu/docs/en_GB/document_ library/Scientific_guideline/2009/09/WC500003517.pdf (дата обращения 14.04.2014).; Guideline on Similar Biological Medicinal Products Containing Biotechnology-derived Proteins as Drug Substance - Non Clinical and Clinical Issues, EMEA/CHMP/BMWP/42832/05, February 2006. URL: http://www.triskel.com/2%20Guideline%20biotech%20derived%20proteins. pdf.; Guideline on Similar Biological MedicinalProducts containing biotechnology-derived proteins as active substance: quality issues (revision 1). EMA, Committee for Medicinal Products for Human Use, 2012. URL:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_ guideline/2012/05/WC500127960.pdf (датаобращения 14.04.2014).; Guideline on Similar Biological Medicinal Products Containing Low-molecular Weight Heparins. Draft released for consultation in April 2008. URL: www.ema.europa.eu/pdfs/human/biosimilar/11826407en.; Guideline on similar biological medicinal products containing monoclonal antibodies - non-clinical and clinical issues, CHMP/ BMWP/403543/2010, May 2012. URL:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/ WC500128686.pdf.; Guideline on similar biological medicinal products containing recombinant interferon alpha, CHMP/BMWP/102046/2006, October 2007. URL:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003931.pdf.; IMS Health 2007 & 2009, Evaluate Pharma, Sandoz analysis.; Jenkins N., Murphy L., Tyther R. Post-translational modifications of recombinant proteins: significance for biopharmaceuticals. // Mol. Biotechnol.- 2008. - № 39. - Р. 113-118.; Misra A. Are biosimilars really generics? // Expert Opin. Biol. Ther. - 2010. - № 10(4). - Р. 489-494.; Goldsmith D., Kuhlmann M., Covic A. Through the looking glass: the protein science of biosimilars. // ClinExpNephrol. 2007;11: 191 - 195.; Sahoo N., Choudhury K., Manchikanti P. Manufacturing of biodrugs: need for harmonization in regulatory standards. // Biodrugs. 2009;23: 217-229.; The Commission of the European Communities (2003) Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. // In Official Journal of the European Union. - L159. - Р. 46-94.; The European Parliament and the Council of the European Union (2004) Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. // In Official Journal of the European Union, L136, pp. 34-57.; https://www.pharmacokinetica.ru/jour/article/view/148
Availability: https://www.pharmacokinetica.ru/jour/article/view/148
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4Academic Journal
Source: Фармакокинетика и фармакодинамика.
Subject Terms: БИОСИМИЛЯР, БИОТЕХНОЛОГИЯ, БИОАНАЛОГ, ПОДОБНЫЙ БИОЛОГИЧЕСКИЙ ЛЕКАРСТВЕННЫЙ ПРОДУКТ, ДЖЕНЕРИКИ
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