19. Sergey Zyrynov - Pirogov University (Russian Federation)

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  3. 3. ? : - !Crommelin DJA, et al. Int J Pharm 2003;266:3-16.
  4. 4. , Schellekens H. Nat Rev Drug Discov 2002:45762
  5. 5. ()/ % 5,9 % (+ MTX) 25,6 % (-MTX) 0,6 % (+MTX) 12,4 % (-MTX)/ 38 % (3 /) 12 % (6 /) 2,9 %/ 6 % 7,5 %2 % 7 % 9,7 % 3 %=
  6. 6. -1a Bertolotto et al J Neurology 2004 () (/) - (%)Jacobs et al. (1996) [14] 30 22*Herden et al. (1999) [10] 1 20 30 5Rudick et al. (1998) [34] 1 20 30 6Jacobs et al. (2000) [13] 1 20 30 2Clanet et al. (2002) [4] 1 20 30 60 2,35,8/ ; * , , Jacobs et al. [14] , .
  7. 7. ~44% (5% IgE) - 3-16% 1:10 000 VIII ~35% IFN- . ~25% IL-2 20-100% (H.Schellekens, 2002)
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  9. 9. (, )PRISMS 4 (2005) . IFN (1996) . IFN (1998) (1999) Deisenhammer et al. (1999) MxA Cook et al. (2001) ; ; Vallittu et al. (2002) ; MxA 22 Bertolotto et al. (2005) ; MxA; 22;Pachner et al. (2003) ; MxA; Malucchi et al. (2004) ; 22;Petkau et al. (2004) ; MxA Perini et al. (2004) ; 22;Kappos et al. (2005) 30 ; 60 Sorensen et al. (2003) 30 OW; 22 OW; 22 TTW; 8 /2 . R.A. Farrell G. Giovannoni, (Measuring and management of anti-interferon beta antibodies in subjects with multiple sclerosis), Mult. Scler. 13 (5) (Jun 2007), pp. 567577. -
  10. 10. 5. () Bartelds, G. M. et al. JAMA 2011;305:1460-1468Copyright restrictions may apply.
  11. 11. - Benichou et al . (2008)
  12. 12. = - , , : Article 10 (2) b of Directive 2001/83 as amended ?
  13. 13. amended Directive 2001/83/EC(2003/63/EC, 2004/27/EC)Overarching Guidelines(CHMP/437/04)Quality Guidelines(CHMP/49348/05)Non-Clin & Clin Guidelines(CHMP/42832/05)r-Human Insulin Guidance(CHMP/42832/05)Somatropin Guidance(CHMP/94528/05)r-GCSF Guidance(CHMP/31329/05)r-Erythropoeitin Guidance(CHMP/94526/05)Immunogenicity Guidance(CHMP/14327/06)Low Molecular Weight HeparinGuidance (CHMP/118264/2007)r- -Interferon Guidance(CHMP/102046/06)Guidelines under preparation
  14. 14. Singh A. K.Brigham and Womens hospital & Harvard Medical School,Boston, USA.World Congress of Nephrology Apr 22, 2007 47 :, , , , , ,, , , , , , ,, . ()Singh AK. Poster presented at the World Congress of Nephrology, 21-25 April 2007, Rio de Janeiro, Brazil
  15. 15. 15 Singh A. K. pH 9 21 1 8 In vitro1 18 In vivo 48% 163% 9 6 2 Singh AK. Poster presented at the World Congress of Nephrology, 21-25 April 2007, Rio de Janeiro, Brazil
  16. 16. 16 29 - 7 > 1% < 2% 4 2% 4% 18 > 4% 34 , 9 34 3 Singh A. K.Singh AK. Poster presented at the World Congress of Nephrology, 21-25 April 2007, Rio de Janeiro, Brazil
  17. 17. () in-vitro in-vivo % (EU/ml) % (Eprex) 80-125 80-125 < 2,5 < 1 1 94 73 < 0,5 < 1 2 175 76 < 0,5 2,4 1 84 91 < 0,5 1,7 1 167 135 < 0,5 1,2 2 155 117 < 0,5 >4 3 175 149 < 0,5 < 1 170 163 < 0,5 > 4 141 95 < 0,5 2,7 141 48 < 0,5 > 4 1 139 97 < 0,5 > 4 2 132 101 < 0,5 > 4 3 141 90 < 0,5 > 4 153 113 < 0,5 > 4 110 108 < 0,5 > 4 177 57 > 2,5 > 4 142 < 0,5 > 4
  18. 18. 123 123 12 123o 123 12 12 0 1 2 3 4 5 ()
  19. 19. : ; 42 47 34 , 2 , 22 2% , , , Singh AK. Poster presented at the World Congress of Nephrology, 21-25 April 2007, Rio de Janeiro, Brazil
  20. 20. 20July 09ASHAbstract &Poster #Immunogenicity of Low Molecular Weight Heparins and TheirBiosimilarsW.P.JeskeJ.Walenga -
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