-
2
-
-
84860604626
-
-
online]. Available from URL Accessed 2012 Mar 21]
-
Public Health Service (PHS) Act in Section 262: Regulation of biological products [online]. Available from URL: http://www.fda.gov/Regulatory Information/Legislation/FederalFoodDrugandCosmeticActFDCAct/Signif icantAmendmentstotheFDCAct/FDAMA/FullTextofFDAMAlaw/default.htm [Accessed 2012 Mar 21]
-
Public Health Service (PHS) Act in Section 262: Regulation of biological products
-
-
-
3
-
-
64149127559
-
Pharmacokinetic and pharmacodynamic profile of new biosimilar filgrastim XM02 equivalent to marketed filgrastim Neupogen: Single-blind, randomized, crossover trial
-
Lubenau H, Bias P, Maly AK, et al. Pharmacokinetic and pharmacodynamic profile of new biosimilar filgrastim XM02 equivalent to marketed filgrastim Neupogen: single-blind, randomized, crossover trial. BioDrugs 2009; 23 (1): 43-51
-
(2009)
Bio. Drugs
, vol.23
, Issue.1
, pp. 43-51
-
-
Lubenau, H.1
Bias, P.2
Maly, A.K.3
-
4
-
-
79953165772
-
Evaluation of process efficiency and bioequivalence of biosimilar recombinant human chorionic gonadotropin (rhCG)
-
Seo KS, Yoon JW, Na KH, et al. Evaluation of process efficiency and bioequivalence of biosimilar recombinant human chorionic gonadotropin (rhCG). BioDrugs 2011; 25 (2): 115-27
-
(2011)
Bio. Drugs
, vol.25
, Issue.2
, pp. 115-127
-
-
Seo, K.S.1
Yoon, J.W.2
Na, K.H.3
-
5
-
-
78449273913
-
Bioequivalence studies of omnitrope, the first biosimilar/rhGH follow-on protein: Two comparative phase 1 randomized studies and population pharmacokinetic analysis
-
Nov
-
Stanhope R, Sorgel F, Gravel P, et al. Bioequivalence studies of omnitrope, the first biosimilar/rhGH follow-on protein: two comparative phase 1 randomized studies and population pharmacokinetic analysis. J Clin Pharmacol 2010 Nov; 50 (11): 1339-48
-
(2010)
J. Clin. Pharmacol.
, vol.50
, Issue.11
, pp. 1339-1348
-
-
Stanhope, R.1
Sorgel, F.2
Gravel, P.3
-
6
-
-
82155188444
-
Biosimilars: A regulatory perspective from America
-
May 12
-
Kay J. Biosimilars: a regulatory perspective from America. Arthritis Res Ther 2011 May 12; 13 (3): 112
-
(2011)
Arthritis Res. Ther.
, vol.13
, Issue.3
, pp. 112
-
-
Kay, J.1
-
7
-
-
84860636933
-
-
Seoul: Hanwha Chemical Co. (Data on file)
-
Investigator's Brochure of HD203. Seoul: Hanwha Chemical Co., 2010. (Data on file)
-
(2010)
Investigator's Brochure of HD203
-
-
-
9
-
-
0017743953
-
Influence of height, weight and obesity on risk of breast cancer in an unselected Swedish population
-
Dec
-
Adami HO, Rimsten A, Stenkvist B, et al. Influence of height, weight and obesity on risk of breast cancer in an unselected Swedish population. Br J Cancer 1977 Dec; 36 (6): 787-92
-
(1977)
Br. J. Cancer
, vol.36
, Issue.6
, pp. 787-792
-
-
Adami, H.O.1
Rimsten, A.2
Stenkvist, B.3
-
11
-
-
33745232468
-
Bioequivalence of liquid and reconstituted lyophilized etanercept subcutaneous injections
-
Jun
-
Sullivan JT, Ni L, Sheelo C, et al. Bioequivalence of liquid and reconstituted lyophilized etanercept subcutaneous injections. J Clin Pharmacol 2006 Jun; 46 (6): 654-61
-
(2006)
J. Clin. Pharmacol.
, vol.46
, Issue.6
, pp. 654-661
-
-
Sullivan, J.T.1
Ni, L.2
Sheelo, C.3
-
12
-
-
25844468887
-
-
Guideline on bioanalytical method validation. European Medicines Agency [online]. Available from URL Accessed 2012 Mar 27
-
Commitee for Medicinal Products for Human Use. Guideline on bioanalytical method validation. European Medicines Agency, 2011 [online]. Available from URL: http://www.ema.europa.eu/docs/en-GB/document-library/Sci entific-guideline/2011/08/WC500109686.pdf [Accessed 2012 Mar 27]
-
(2011)
Commitee for Medicinal Products for Human Use
-
-
-
13
-
-
0032825293
-
Open questions on bioequivalence: Some problems and some solutions
-
Oct
-
Marzo A. Open questions on bioequivalence: some problems and some solutions. Pharmacol Res 1999 Oct; 40 (4): 357-68
-
(1999)
Pharmacol. Res.
, vol.40
, Issue.4
, pp. 357-368
-
-
Marzo, A.1
-
14
-
-
0034918119
-
Proof of efficacy trials: Cross-over versus parallel-group
-
May discussion 9-51
-
Richens A. Proof of efficacy trials: cross-over versus parallel-group. Epilepsy Res 2001 May; 45 (1-3): 43-7; discussion 9-51
-
(2001)
Epilepsy Res.
, vol.45
, Issue.1-3
, pp. 43-47
-
-
Richens, A.1
-
15
-
-
22344444432
-
Mechanisms of differential immunogenicity of tumor necrosis factor inhibitors
-
Mar
-
Anderson P, Louie J, Lau A, et al. Mechanisms of differential immunogenicity of tumor necrosis factor inhibitors. Curr Rheumatol Rep 2005 Mar; 7 (1): 3-9
-
(2005)
Curr. Rheumatol. Rep.
, vol.7
, Issue.1
, pp. 3-9
-
-
Anderson, P.1
Louie, J.2
Lau, A.3
-
16
-
-
77749277255
-
Legislative initiatives in Europe, Canada and the US for market authorization of follow-on biologics
-
Mar
-
Looper YJ. Legislative initiatives in Europe, Canada and the US for market authorization of follow-on biologics. Curr Opin Drug Discov Devel 2010 Mar; 13 (2): 247-56
-
(2010)
Curr. Opin. Drug Discov. Devel.
, vol.13
, Issue.2
, pp. 247-256
-
-
Looper, Y.J.1
-
17
-
-
84860627415
-
-
Korea Food Guidelines on the evaluation of biosimilar products Jul [online]. Available from URL Accessed 2012 Mar 21
-
Korea Food and Drug Administration. Guidelines on the evaluation of biosimilar products, 2009 Jul [online]. Available from URL: http://www.kfda. go.kr/index.kfda?mid=226 [Accessed 2012 Mar 21]
-
(2009)
Drug Administration
-
-
-
18
-
-
6344261597
-
Absence of a clinically relevant interaction between etanercept and digoxin
-
Nov
-
Zhou H, Parks V, Patat A, et al. Absence of a clinically relevant interaction between etanercept and digoxin. J Clin Pharmacol 2004 Nov; 44 (11): 1244-51
-
(2004)
J. Clin. Pharmacol.
, vol.44
, Issue.11
, pp. 1244-1251
-
-
Zhou, H.1
Parks, V.2
Patat, A.3
-
19
-
-
1942508209
-
Absence of a pharmacokinetic interaction between etanercept and warfarin
-
May
-
Zhou H, Patat A, Parks V, et al. Absence of a pharmacokinetic interaction between etanercept and warfarin. J Clin Pharmacol 2004 May; 44 (5): 543-50
-
(2004)
J. Clin Pharmacol.
, vol.44
, Issue.5
, pp. 543-550
-
-
Zhou, H.1
Patat, A.2
Parks, V.3
-
20
-
-
33644990468
-
The comparability of etanercept pharmacokinetics in healthy Japanese and American subjects
-
Apr
-
Kawai S, Sekino H, Yamashita N, et al. The comparability of etanercept pharmacokinetics in healthy Japanese and American subjects. J Clin Pharmacol 2006 Apr; 46 (4): 418-23
-
(2006)
J. Clin. Pharmacol.
, vol.46
, Issue.4
, pp. 418-423
-
-
Kawai, S.1
Sekino, H.2
Yamashita, N.3
-
21
-
-
0033975145
-
The pharmacokinetics of etanercept in healthy volunteers
-
Feb
-
Korth-Bradley JM, Rubin AS, Hanna RK, et al. The pharmacokinetics of etanercept in healthy volunteers. Ann Pharmacother 2000 Feb; 34 (2): 161-4
-
(2000)
Ann. Pharmacother.
, vol.34
, Issue.2
, pp. 161-164
-
-
Korth-Bradley, J.M.1
Rubin, A.S.2
Hanna, R.K.3
-
22
-
-
79955806736
-
Integrated population pharmacokinetics of etanercept in healthy subjects and patients with rheumatoid arthritis and ankylosing spondylitis
-
Zhou SY, Shu C, Korth-Bradley J, et al. Integrated population pharmacokinetics of etanercept in healthy subjects and patients with rheumatoid arthritis and ankylosing spondylitis. J Clin Pharmacol 2011; 51 (6): 864-75
-
(2011)
J. Clin. Pharmacol.
, vol.51
, Issue.6
, pp. 864-875
-
-
Zhou, S.Y.1
Shu, C.2
Korth-Bradley, J.3
-
23
-
-
78149403810
-
Population pharmacokinetics of rhtnfr-fc in healthy chinese volunteers and in chinese patients with ankylosing spondylitis
-
Nov
-
Fang Y, Li LJ, Wang R, et al. Population pharmacokinetics of rhTNFR-Fc in healthy Chinese volunteers and in Chinese patients with ankylosing spondylitis. Acta Pharmacol Sin 2010 Nov; 31 (11): 1500-7
-
(2010)
Acta. Pharmacol. Sin.
, vol.31
, Issue.11
, pp. 1500-1507
-
-
Fang, Y.1
Li, L.J.2
Wang, R.3
-
24
-
-
79955806736
-
Integrated population pharmacokinetics of etanercept in healthy subjects and in patients with rheumatoid arthritis and ankylosing spondylitis
-
Jun
-
Zhou SY, Shu C, Korth-Bradley J, et al. Integrated population pharmacokinetics of etanercept in healthy subjects and in patients with rheumatoid arthritis and ankylosing spondylitis. J Clin Pharmacol 2011 Jun; 51 (6): 864-75
-
(2011)
J. Clin. Pharmacol.
, vol.51
, Issue.6
, pp. 864-875
-
-
Zhou, S.Y.1
Shu, C.2
Korth-Bradley, J.3
-
25
-
-
84860636932
-
Randomized double-blind parallel trial to evaluate equivalence in efficacy and safety of HD203 and Enbrel in RA patients [Clinical- Trials.gov identifier NCT01270997
-
Hanwha Chemical online Available from URL Accessed 2012 Mar 21]
-
Hanwha Chemical. Randomized double-blind parallel trial to evaluate equivalence in efficacy and safety of HD203 and Enbrel in RA patients [Clinical- Trials.gov identifier NCT01270997]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://www/clinicaltrials. gov [Accessed 2012 Mar 21]
-
US National Institutes of Health Clinical Trials.Gov.
-
-
|