-
1
-
-
19044395847
-
Follow-on biologics: Challenges of the 'next generation'
-
Schellekens H. Follow-on biologics: challenges of the 'next generation'. Nephrol Dial Transplant 2005;20(Suppl 4):iv31-iv36
-
(2005)
Nephrol Dial Transplant
, vol.20
, Issue.SUPPL. 4
-
-
Schellekens, H.1
-
2
-
-
34249848744
-
-
EGA, Available at, last accessed 5 March 2008
-
EGA. Frequently asked questions about generic medicines. 2007; Available at www.egagenerics.com/FAQ-generics.htm [last accessed 5 March 2008]
-
(2007)
Frequently asked questions about generic medicines
-
-
-
3
-
-
55549101763
-
-
EMEA. Questions and answers on generic medicines. EMEA Document EMEA/ 393905/2006 April 2007. Available at www.emea.europa.eu/pdfs/buman/pcwp/ 39390506en.pdf [last accessed 24 July 2008]
-
EMEA. Questions and answers on generic medicines. EMEA Document EMEA/ 393905/2006 April 2007. Available at www.emea.europa.eu/pdfs/buman/pcwp/ 39390506en.pdf [last accessed 24 July 2008]
-
-
-
-
5
-
-
34548147147
-
Basic facts about biosimilars
-
Nowicki M. Basic facts about biosimilars. Kidney Blood Press Res 2007;30:267-72
-
(2007)
Kidney Blood Press Res
, vol.30
, pp. 267-272
-
-
Nowicki, M.1
-
6
-
-
33748687181
-
The protein science of biosimilars
-
Kuhlmann M, Covic A. The protein science of biosimilars. Nephrol Dial Transplant 2006;21(Suppl 5):v4-v8
-
(2006)
Nephrol Dial Transplant
, vol.21
, Issue.SUPPL. 5
-
-
Kuhlmann, M.1
Covic, A.2
-
7
-
-
32944467835
-
Mass spectrometrical analysis of recombinant human growth hormone Norditropin reveals amino acid exchange at M14_V14 rhGH
-
Hepner F, Csaszar E, Roitinger E, et al. Mass spectrometrical analysis of recombinant human growth hormone Norditropin reveals amino acid exchange at M14_V14 rhGH. Proteomics 2006;6:775-84
-
(2006)
Proteomics
, vol.6
, pp. 775-784
-
-
Hepner, F.1
Csaszar, E.2
Roitinger, E.3
-
8
-
-
28844464783
-
Mass spectrometrical analysis of recombinant human growth hormone (Genotropin(R)) reveals amino acid substitutions in 2% of the expressed protein
-
Hepner F, Cszasar E, Roitinger E, et al. Mass spectrometrical analysis of recombinant human growth hormone (Genotropin(R)) reveals amino acid substitutions in 2% of the expressed protein. Proteome Sci 2005;3:1
-
(2005)
Proteome Sci
, vol.3
, pp. 1
-
-
Hepner, F.1
Cszasar, E.2
Roitinger, E.3
-
9
-
-
0025184040
-
Sialylated carbohydrate chains of recombinant human glycoproteins expressed in Chinese hamster ovary cells contain traces of N-glycolylneuraminic acid
-
Hokke CH, Bergwerff AA, van Dedem GW, et al. Sialylated carbohydrate chains of recombinant human glycoproteins expressed in Chinese hamster ovary cells contain traces of N-glycolylneuraminic acid. FEBS Lett 1990;275:9-14
-
(1990)
FEBS Lett
, vol.275
, pp. 9-14
-
-
Hokke, C.H.1
Bergwerff, A.A.2
van Dedem, G.W.3
-
10
-
-
0028071196
-
Generation of Chinese hamster ovary cell glycosylation mutants by retroviral insertional mutagenesis. Integration into a discrete locus generates mutants expressing high levels of N-glycolylneuraminic acid
-
Hubbard SC, Walls L, Ruley HE, et al. Generation of Chinese hamster ovary cell glycosylation mutants by retroviral insertional mutagenesis. Integration into a discrete locus generates mutants expressing high levels of N-glycolylneuraminic acid. J Biol Chem 1994;269:3717-24
-
(1994)
J Biol Chem
, vol.269
, pp. 3717-3724
-
-
Hubbard, S.C.1
Walls, L.2
Ruley, H.E.3
-
11
-
-
13844267152
-
Human embryonic stem cells express an immunogenic nonhuman sialic acid
-
Martin MJ, Muotri A, Gage F, et al. Human embryonic stem cells express an immunogenic nonhuman sialic acid. Nat Med 2005;11:228-32
-
(2005)
Nat Med
, vol.11
, pp. 228-232
-
-
Martin, M.J.1
Muotri, A.2
Gage, F.3
-
12
-
-
55549135871
-
Questions and answers on biosimilar medicines (similar biological medicinal products)
-
EMEA/74562/2006 June 2007. Available at, last accessed 24 July 2008
-
EMEA. Questions and answers on biosimilar medicines (similar biological medicinal products). EMEA Document EMEA/74562/2006 June 2007. Available at www.emea.europa.eu/pdfs/human/pcwp/7456206en.pdf [last accessed 24 July 2008]
-
EMEA Document
-
-
-
13
-
-
33748685217
-
Comparative testing and pharmacovigilance of biosimilars
-
Locatelli F, Roger S. Comparative testing and pharmacovigilance of biosimilars. Nephrol Dial Transplant 2006; 21(Suppl 5):v13-v6
-
(2006)
Nephrol Dial Transplant
, vol.21
, Issue.SUPPL. 5
-
-
Locatelli, F.1
Roger, S.2
-
14
-
-
33748682929
-
-
Kessler M, Goldsmith D, Schellekens H. Immunogenicity of biopharmaceuticals, Nephrol Dial Transplant 2006; 21(Suppl 5):v9-vl2
-
Kessler M, Goldsmith D, Schellekens H. Immunogenicity of biopharmaceuticals, Nephrol Dial Transplant 2006; 21(Suppl 5):v9-vl2
-
-
-
|