Диссертация (1141353), страница 18
Текст из файла (страница 18)
– 2004. –№22. – Р. 1383 – 139152. CovicA,Cannata-AndiaJ,CancariniGetal.Biosimilarsandbiopharmaceuticals: what the nephrologists need to know – a position paper bythe ERA-EDTA Council // Nephrol Dial Transplant.– 2008. – №23. – Р. 3731 –373753. Crommelin DJ, Bermejo T, Bissig M et al. Pharmaceutical evaluation ofbiosimilars: important differences from generic low-molecular weight pharm //Eur J Hosp Pharm Sci.
–2005. – №1. – Р. 11 – 1754. Defronzo RA, Ratner RE, Han J, Kim DD, Fineman MS, Baron AD. Effects ofexenatide (exendin-4) on glycemic control and weight over 30 weeks inmetformin-treated patients with type 2 diabetes // Diabetes Care. – 2005. –№28. – Р. 1092 – 110013655.
Defronzo RA, Hissa MN, Garber AJ, Luiz GJ, Yuyan DR, Ravichandran S,Chen RS. The efficacy and safety of saxagliptin when added to metformintherapy in patients with inadequately controlled type 2 diabetes with metforminalone // Diabetes Care. –2009. –№32. – Р. 1649 – 165556.
European Medicines Agency Committee for Medicinal Products for HumanUse. Guideline on non-clinical and clinical development of similar biologicalmedicinalproductscontainingrecombinanterythropoietins(Revision)EMEA/CHMP/BMWP/301636/2008 Corr. London, 200857. FDA, Electronics Orange Book: Approved Drug Products with TherapeuticEquivalence Evaluations58. Fox Andrew. Biosimilar medicines–New Challenges for a New Class ofmedicine // Journal of Biopharmaceutical Statistics. – 2010. – №20 [1].
– Р. 3 –959. Forst T, Uhlig-Laske B, Ring A, Graefe-Mody U, Friedrich C, Herbach K,Woerle HJ, Dugi KA. Linagliptin (BI 1356), a potent and selective DPP-4inhibitor, is safe and efficacious in combination with metformin in patients withinadequately controlled type 2 diabetes // Diabet Med. – 2010. – №27. – Р.1409 – 141960. Guidelines on the quality, safety, and efficacy of biotherapeutic proteinproducts prepared by recombinant DNA technology, 2013. Replacement ofAnnex 3 of WHO Technical Report Series, № 814.
WHO Expert Committee onbiological Standardization61. Grabowski H, Cockburn I, Long G. The market for the follow-on biologics:how will it evolve? // Health Aff (Millwood). – 2006. – №2[5]. – Р. 1291 –130162. Drug Price Competition and Patent Term Restoration Act. Public law. USA63.
Hollander P, Li J, Allen E, Chen R. Saxagliptin added to a thiazolidinedioneimproves glycemic control in patients with type 2 diabetes and inadequatecontrol on thiazolidinedione alone // J Clin Endocrinol Metab. – 2009 – №94. –Р. 4810 – 481913764. ICH guideline S6 (R1) Preclinical safety evaluation of biotechnology-derivedpharmaceuticals.
EMA/CHMP/ICH/731268/199865. ICH Q5D Derivation and Characterization of Cell Substrates Used forProductionofBiotechnological/BiologicalProducts.InternationalConference on Harmonisation; 199766. ICH Q5A Viral Safety Evaluation of Biotechnology Products Derived fromCell Lines of Human or Animal Origin. International Conference onHarmonisation; 199767. ICHtopicQ5E,Step5Biotechnological/Biological/ProductsNoteSubjectfortoGuidancechangesinontheirManufacturing Process.
CHMP/ICH/5721/03. EMA. June 200568. Kanavos P. Do generics offer significant savings to the UK National HealthService? // Curr Med Res Opin. – 2007. – №23[1]. – Р. 105 – 11669. Martino M, Console G, Irrera G, Callea I, Condemi A, Dattola A, et al.Harvesting peripheral blood progenitor cells from healthy donors: retrospectivecomparison of filgrastim and lenograstim // J Clin Apher. – 2005.
– №20[3]. –P. 129 – 13670. Milstein, C. The hybridoma revolution: an offshoot of basic research //Bioessays. – 1999. –№21. –. P. 966 – 97371. Mellstedt H. The future of biosimilars // Hosp Pharm Europe. – 2010. – №49. –Р. 33 – 3472.
Midtvedt K, Fauchald P, Lien B, et al. Individualized T cell monitoredadministration of ATG versus OKT3 in steroid-resistant kidney graft rejection //Clinical transplantation. – 2003. – №17]1]. – P. 69 – 7473. Patient protection and Affordable Care Act. Public law.
USA74. Praditpornsilpa K, Tiranathanagul P, Saengsuree J et al. Biosimilarrecombinant human erythropoietin induces the production of neutralizingantibodies // Kidney International. –2011. – №80. – Р. 88 - 9275. Preithner S, Elm S, Lippold S, Locher M, Wolf A, da Silva AJ, et al.High concentrations of therapeutic IgG1 antibodies are needed to compensate138for inhibition of antibody-dependent cellular cytotoxicity by excess endogenousimmunoglobulin G // Mol. Immunol.
– 2006. – №43[8]. P. 1183 – 9376. Reichert J. Monoclonal antibodies as innovative therapeutics // CurrentPharmaceutical Biotechnology. – 2008. – №9. – Р. 423 – 43077. Reichert J., Rosenweig C. et al. Monoclonal antibody successes in the clinic //Nature Biotechnology. – 2005. – Vol.23. №9. – Р.
1073 – 107878. Reichert J. Monoclonal antibodies as innovative therapeutics // CurrentPharmaceutical Biotechnology. – 2008. – №9. – Р. 423 - 43079. Querol S, Cancelas JA, Amat L, Capmany G, Garcia J. Effect of glycosylationof recombinant human granulocytic colony-stimulating factor on expansioncultures of umbilical cord blood CD34 + cells // Haematologica. – 1999.
–№84. Р. 493 – 49880. Similar biological medicinal products/ ref. № Committee for MedicinalProducts for Human Use (CHMP)./437/04 Rev. 1. Eff.data – 30.04.201581. Similar biological medicinal products containing biotechnology-derivedproteinsasactivesubstance:non-clinicalandclinicalissues.EMEA/CHMP/BMWP/42832/2005 Rev. 1. Eff.data – 01.07.201582. Similar biological medicinal products containing biotechnology-derivedproteins as active substance: quality issues/ EMA/CHMP/BWP/247713/2012.Eff.data-01.12.201483. Schellekens H. Biosimilar therapeutics - what do we need to consider? // NDPPlus. –2009.
–№2[Suppl 1]. – Р. 27-3684. Schellekens H. Bioequivalence and the immunogenicity of biopharmaceuticals// Drug Discovery. – 2002. – №1. – Р. 457 – 46285. Schellekens Y. Biosimilar epoetins: how similar are they? // Hosp PharmEurope. – 2004. – №3. – Р. 43 - 4786. Schneeweis S, Setoguchi S, Weinblatt M, Katz JN, Avorn J, Sax PE, et al.Antitumor necrosis factor alphatherapy and the risk of serious bacterialinfections in elderly patients with rheumatoid arthritis // Arthr. Rheum. – 2007.– №56[6].
P. 1754 – 176413987. Scott A, Allison J., Wolchok J. Monoclonal antibodies in cancer therapy //Сancer immunity. – 2012. –Vol. 12. – P. 1488. Silverstein A. Labeled antigens and antibodies: the evolution of magic markersand magic ballets // Nature immunology. Vol.5. №12. р. 1211-121789.
Simoens S. Biosimilar medicines and cost-effectiveness. Clinicoeconomics andOutcomes Research. – 2011. – №3. – Р. 29 – 3690. Studnicka GM, Soares S., Better, M., Williams, RE, Nadell, R., and Horwitz,AH. Human-engineered Mabs retain full specific binding activity by preservingnon-CDR complementarity-modulating residues // Protein Eng. – 1994. – №7[6]. – P. 805 – 81491.
Teramura M, Kimura A, Iwase S, Yonemura Y, Nakao S, Urabe A, et al.Treatment of severe aplastic anemia with antithymocyte globulin andcyclosporin A with or without G-CSF in adults: a multicenter randomized studyin Japan // Blood. – 2007. – №110[6]. – Р. 1756 – 1761.92. Witzig TE, Gordon LI, Cabanillas F, Czuczman MS, Emmanouilides C, JoyceR, et al. Randomized controlled trial of Yttrium-90-labelled Ibritumomabtiuxetan radioimmunotherapy versus rituximab immunotherapy for patientswith relapsed or refractory low grade, follicular or transformed B-cell nonHodgkin’s lymphoma // J Clin Oncol. – 2002. – №20[10].
– Р. 2453 – 246393. WHO Drug Information (World Health Organization) «InternationalNonproprietary Names». 23 (3): 195–199. 2009. Retrieved 2010-12-0894. www.bio.org95. www.cbio.ru96. www.cleandex.ru97. www.datamonitor.com98. www.egagenerics.com99. www.dsm.ru100.www.emea.europa.eu101.www.en.my-diabet.com102. www.fda.gov140103. www.imshealth.com104. www.novonordisk.com105. www.pharma2020.ru106. www.pharmexpert.ru107. www.remedium.ru108.
www.rosminzdrav.ru109. www.roszdravnadzor.ru110. www.ru.science.wikia.com111. www.sandoz.com112. www.vfd.de113. www.who.net114. www.zdrav.ru115. ZiderA,DrakemanD.Thefutureofmonoclonalantibodytechnology//Landes Bioscience. 2010. 361-364116. Zhiqiang Аn.Antibody Therapeutics – a mini review // Сancerimmunotherapy.
№2. 2008. Р. 24-29117. Zuniga L, Calvo B. Biosimilars – the way forward // Hosp Pharm Europe. –2010. – №50. – Р. 33 – 34141.
![](https://s.studizba.com/z.php?f=/templates/si/i/noavatar.png&w=100&h=100&t=1"){kind=avatar}
