-
2
-
-
19044395847
-
Follow-on biologics: Challenges of the 'next genera-tion'
-
Schellekens H. Follow-on biologics: challenges of the 'next genera-tion'. Nephrol Dial Transplant 2005;20(suppl 4):iv31-6
-
(2005)
Nephrol Dial Transplant
, vol.20
, Issue.SUPPL. 4
-
-
Schellekens, H.1
-
3
-
-
77956225724
-
-
European Medicines Agency 22 October 2008 Doc. ref. EMEA/74562/2006 rev.1. London: EMA
-
European Medicines Agency. Questions and Answers on biosimilar medicines (similar biological medicinal products). 22 October 2008 Doc. ref. EMEA/74562/2006 rev.1. London: EMA, 2008. http://www. emea.europa.eu/pdfs/human/ pcwp/7456206en.pdf
-
(2008)
Questions and Answers on Biosimilar Medicines (Similar Biological Medicinal Products)
-
-
-
4
-
-
0036499495
-
'Biogenerics': The off-patent biotech products
-
Schellekens H, Ryff JC. 'Biogenerics': the off-patent biotech products Trends Pharmacol Sci 2002;23:119-21
-
(2002)
Trends Pharmacol Sci
, vol.23
, pp. 119-21
-
-
Schellekens, H.1
Ryff, J.C.2
-
5
-
-
33748685217
-
Comparative testing and pharmacovigilance of biosimilars
-
Locatelli F, Roger S. Comparative testing and pharmacovigilance of biosimilars. Nephrol Dial Transplant 2006;21(suppl 5):v13-16.
-
(2006)
Nephrol Dial Transplant
, vol.21
, Issue.SUPPL. 5
-
-
Locatelli, F.1
Roger, S.2
-
6
-
-
35748959960
-
Pure red-cell aplasia 'epidemic' mystery completely revealed?
-
Locatelli F, Del Vecchio L, Pozzoni P. Pure red-cell aplasia 'epidemic' mystery completely revealed? Perit Dial Int 2007;27(suppl 2):S303-07
-
(2007)
Perit Dial Int
, vol.27
, Issue.SUPPL. 2
-
-
Locatelli, F.1
Del Vecchio, L.2
Pozzoni, P.3
-
7
-
-
0037075272
-
Pure red-cell aplasia and antieryth-ropoietin antibodies in patients treated with recombinant erythropoi-etin
-
Casadevall N, Nataf J, Viron B et al. Pure red-cell aplasia and antieryth-ropoietin antibodies in patients treated with recombinant erythropoi-etin. N Engl J Med 2002;346:469-75
-
(2002)
N Engl J Med
, vol.346
, pp. 469-75
-
-
Casadevall, N.1
Nataf, J.2
Viron, B.3
-
8
-
-
15844367464
-
Immunologic mechanisms of EPO-associated pure red cell aplasia
-
Schellekens H. Immunologic mechanisms of EPO-associated pure red cell aplasia. Best Pract Res Clin Haematol 2005;18:473-80
-
(2005)
Best Pract Res Clin Haematol
, vol.18
, pp. 473-80
-
-
Schellekens, H.1
-
9
-
-
33748687181
-
The protein science of biosimilars
-
Kuhlmann M, Covic A. The protein science of biosimilars. Nephrol Dial Transplant 2006;21(suppl 5):v4-8
-
(2006)
Nephrol Dial Transplant
, vol.21
, Issue.SUPPL. 5
-
-
Kuhlmann, M.1
Covic, A.2
-
10
-
-
33746169811
-
Biosimilars: How similar or dissimilar are they?
-
Roger SD. Biosimilars: how similar or dissimilar are they? Nephrology 2006;11:341-6
-
(2006)
Nephrology
, vol.11
, pp. 341-6
-
-
Roger, S.D.1
-
12
-
-
0022718786
-
Insulin allergy
-
Grammer L. Insulin allergy. Clin Rev Allergy 1986;4:189-200
-
(1986)
Clin Rev Allergy
, vol.4
, pp. 189-200
-
-
Grammer, L.1
-
14
-
-
36048991061
-
Insulin: History, biochemistry, physiology and pharmacology
-
Joshi SR, Parikh RM, Das AK. Insulin: history, biochemistry, physiology and pharmacology. J Assoc Physicians India 2007;55(suppl):19-25
-
(2007)
J Assoc Physicians India
, vol.55
, Issue.SUPPL.
, pp. 19-25
-
-
Joshi, S.R.1
Parikh, R.M.2
Das, A.K.3
-
15
-
-
77957129813
-
The history of diabetes
-
accessed 10 May 2009
-
Sattley M. The history of diabetes. Diabetes Health 2008. http://www. diabeteshealth.com/read/2008/12/17/71 5/the-history-of-diabetes/ (accessed 10 May 2009)
-
Diabetes Health 2008
-
-
Sattley, M.1
-
16
-
-
77957150048
-
-
Insulin: A Voice for Choice. Basel Karger, 2007;10-13. accessed 10 May 2009
-
Teuscher A. The history of insulin. In: Insulin: A Voice for Choice. Basel Karger, 2007;10-13. http://content.karger.com/ProdukteDB/Katalogteile/ isbn3-8055/-83/-53/Insulin-02.pdf (accessed 10 May 2009)
-
The History of Insulin
-
-
Teuscher, A.1
-
17
-
-
0037677435
-
Metabolic load of recombinant pro-tein production: Inhibition of cellular capacities for glucose uptake and respiration after induction of a heterologous gene in Escherichia coli
-
Neubauer RP, Lin HY, Mathiszik B. Metabolic load of recombinant pro-tein production: inhibition of cellular capacities for glucose uptake and respiration after induction of a heterologous gene in Escherichia coli. Biotechnol Bioeng 2003; 83: 53-64.
-
(2003)
Biotechnol Bioeng
, vol.83
, pp. 53-64
-
-
Neubauer, R.P.1
Lin, H.Y.2
Mathiszik, B.3
-
18
-
-
0141831834
-
Bioprocessing of therapeutic proteins from the inclusion bodies of Escherichia coli
-
Panda AK. Bioprocessing of therapeutic proteins from the inclusion bodies of Escherichia coli. Adv Biochem Eng Biotechnol 2003;85 43-93
-
(2003)
Adv Biochem Eng Biotechnol
, vol.85
, pp. 43-93
-
-
Panda, A.K.1
-
19
-
-
0037112617
-
Renaturation of human proinsulin: A study on refolding and conversion to insulin
-
Winter J, Lilie H, Rudolph R. renaturation of human proinsulin: a study on refolding and conversion to insulin. Anal Biochem 2002; 310:148-55
-
(2002)
Anal Biochem
, vol.310
, pp. 148-55
-
-
Winter, J.1
Lilie, H.2
Rudolph, R.3
-
20
-
-
19644389665
-
Solubilization and refolding of bacterial inclusion body proteins
-
Singh AM, Panda AK. Solubilization and refolding of bacterial inclusion body proteins. J Bioscience Bioeng 2005;99:303-10
-
(2005)
J Bioscience Bioeng
, vol.99
, pp. 303-10
-
-
Singh, A.M.1
Panda, A.K.2
-
21
-
-
77957171161
-
Annex guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues
-
Committee for Medicinal Products for Human Use accessed 13 April 2009
-
Committee for Medicinal Products for Human Use. Annex guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Guidance on similar medicinal products containing recombinant human insulin London: EMA, 2006. http://www.emea.europa.eu/pdfs/human/ biosimilar/3277505en.pdf (accessed 13 April 2009)
-
Guidance on Similar Medicinal Products Containing Recombinant Human Insulin London: EMA
, vol.2006
-
-
-
22
-
-
77957139265
-
Insulin
-
Crommelin DJA, Sindelar RD, Meibohm B (eds.) 3rd edition. Informa Healthcare New York
-
Beals JM, DeFilippis MR, Kovach PM. Insulin. In: Crommelin DJA, Sindelar RD, Meibohm B (eds.). Pharmaceutical Biotechnology Fundamentals and Applications, 3rd edition. Informa Healthcare New York, 2008;265-80
-
(2008)
Pharmaceutical Biotechnology Fundamentals and Applications
, pp. 265-80
-
-
Beals, J.M.1
Defilippis, M.R.2
Kovach, P.M.3
-
23
-
-
77957119397
-
-
European Medicines Agency Doc ref EMEA/CHMP/ QWP/178621/2004. London: EMA accessed 10 May 2009
-
European Medicines Agency. Guideline on the suitability of the gradu-ation of delivery devices for liquid dosage forms. Doc ref EMEA/CHMP/ QWP/178621/2004. London: EMA, 2004. http://www.emea.europa eu/pdfs/human/qwp/ 17862104en.pdf (accessed 10 May 2009)
-
Guideline on the Suitability of the Gradu-ation of Delivery Devices for Liquid Dosage Forms
, vol.2004
-
-
-
25
-
-
50049099939
-
Initiating insulin therapy in type 2 diabetes: Benefits of insu-lin analogs and insulin pens
-
Brunton S. Initiating insulin therapy in type 2 diabetes: benefits of insu-lin analogs and insulin pens. Diabetes Technol Ther 2008;10:247-56
-
(2008)
Diabetes Technol Ther
, vol.10
, pp. 247-56
-
-
Brunton, S.1
-
26
-
-
33644961570
-
FlexPen: Addressing issues of confidence and convenience in insulin delivery
-
Korytkowski M, Niskanen L, Asakura T. FlexPen: addressing issues of confidence and convenience in insulin delivery. Clin Ther 2005; 27(suppl B):S89-100
-
(2005)
Clin Ther
, vol.27
, Issue.SUPPL. B
-
-
Korytkowski, M.1
Niskanen, L.2
Asakura, T.3
-
27
-
-
0344233275
-
A multicenter, randomized, open-label, comparative, two-period crossover trial of preference, efficacy, and safety profiles of a prefilled, disposable pen and conventional vial/syringe for insulin injection in patients with type 1 or 2 diabetes mellitus
-
FlexPen Study Team.
-
Korytkowski M, Bell D, Jacobsen C, Suwannasari R. FlexPen Study Team. A multicenter, randomized, open-label, comparative, two-period crossover trial of preference, efficacy, and safety profiles of a prefilled, disposable pen and conventional vial/syringe for insulin injection in patients with type 1 or 2 diabetes mellitus. Clin Ther 2003; 25:2836-48
-
(2003)
Clin Ther
, vol.25
, pp. 2836-48
-
-
Korytkowski, M.1
Bell, D.2
Jacobsen, C.3
Suwannasari, R.4
-
28
-
-
33748707376
-
European regulatory guidelines for biosimilars
-
Wiecek A, Mikhail A. European regulatory guidelines for biosimilars Nephrol Dial Transplant 2006;21(suppl 5):v17-20
-
(2006)
Nephrol Dial Transplant
, vol.21
, Issue.SUPPL. 5
-
-
Wiecek, A.1
Mikhail, A.2
-
29
-
-
33644952525
-
-
Committee for Medicinal Products for Human Use London: EMA accessed 13 April 2009
-
Committee for Medicinal Products for Human Use. Guideline on simi-lar biological medicinal products. London: EMA, 2005. http://www. emea.europa.eu/pdfs/human/biosimilar/043704en.pdf (accessed 13 April 2009)
-
(2005)
Guideline on Simi-lar Biological Medicinal Products
-
-
-
32
-
-
58149464184
-
-
European Medicines Agency 21 February 2008. Document reference EMEA/CHMP/317778/2007 London: EMA accessed 1 May 2009
-
European Medicines Agency. Pre-authorisation Evaluation of Medicines for Human Use. Withdrawal Assessment report for Insulin Human rapid Marvel. 21 February 2008. Document reference EMEA/CHMP/317778/2007 London: EMA, 2008. http://www.emea.europa.eu/humandocs/PDFs/EPAr/insulinhumanrapidmarvel/ 31777807en.pdf (accessed 1 May 2009)
-
(2008)
Preauthorisation Evaluation of Medicines for Human Use. Withdrawal Assessment Report for Insulin Human Rapid Marvel
-
-
-
33
-
-
58149464184
-
-
European Medicines Agency 21 February 2008. Document reference EMEA/CHMP/70349/2008 London: EMA: accessed 1 May 2009
-
European Medicines Agency. Preauthorisation Evaluation of Medicines for Human Use. Withdrawal Assessment report for Insulin Human Long Marvel. 21 February 2008. Document reference EMEA/CHMP/70349/2008 London: EMA: 2008. http://www.emea.europa.eu/humandocs/PDFs/ EPAr/insulinhumanrapidmarvel/ 7034908en.pdf (accessed 1 May 2009)
-
(2008)
Preauthorisation Evaluation of Medicines for Human Use. Withdrawal Assessment Report for Insulin Human Long Marvel
-
-
-
35
-
-
77952509288
-
Lessons learned from biosimilar epoetins and nsulins
-
Kuhlmann M, Marre M. Lessons learned from biosimilar epoetins and nsulins. Br J Diabetes Vasc Dis 2010;10;90-7
-
(2010)
Br J Diabetes Vasc Dis
, vol.10
, pp. 90-7
-
-
Kuhlmann, M.1
Marre, M.2
-
36
-
-
48949118414
-
Points to consider in the evaluation of biopharmaceuticals
-
Krämer I, Tredree R, Vulto AG. Points to consider in the evaluation of biopharmaceuticals. EJHP Practice 2008;14:73-6
-
(2008)
EJHP Practice
, vol.14
, pp. 73-6
-
-
Krämer, I.1
Tredree, R.2
Vulto, A.G.3
-
37
-
-
33748692339
-
Pharmaceutical evaluation of biosimilars: Important differences from generic low-molecular-weight pharmaceuticals
-
Crommelin D, Bermejo T, Bissig M et al. Pharmaceutical evaluation of biosimilars: important differences from generic low-molecular-weight pharmaceuticals. Eur J Hosp Pharm Sci 2005;11:11-7
-
(2005)
Eur J Hosp Pharm Sci
, vol.11
, pp. 11-7
-
-
Crommelin, D.1
Bermejo, T.2
Bissig, M.3
|