-
1
-
-
85008260717
-
-
homepage on the Internet, cited 2014 Jan 23]. Available from
-
European Medicines Agency. Glossary (terms and abbreviations) [homepage on the Internet]. 2014 [cited 2014 Jan 23]. Available from:http://www.ema.europa.eu/ema/index.jsp?curl=pages/document_library/landing/glossary.jsp
-
(2014)
Glossary (terms and abbreviations)
-
-
-
2
-
-
77954882772
-
-
[homepage on the Internet, Mar [cited 2014 Jan 23]. Available from
-
U.S. Food and Drug Administration. Guidance for industry non-inferiority clinical trials. Draft guidance [homepage on the Internet]. 2013 Mar [cited 2014 Jan 23]. Available from: http://www.fda.gov/downloads/Drugs/.../Guidances/UCM202140.pdf
-
(2013)
Guidance for industry non-inferiority clinical trials. Draft guidance
-
-
-
3
-
-
27544475840
-
-
EMEA/CPMP/EWP/2158/99. 27 July, homepage on the Internet]. 2005 Aug [cited 2014 Jan 23]. Available from
-
European Medicines Agency. Guideline on the choice of the non-inferiority margin. EMEA/CPMP/EWP/2158/99. 27 July 2005 [homepage on the Internet]. 2005 Aug [cited 2014 Jan 23]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_ guideline/2009/09/WC500003636.pdf
-
(2005)
Guideline on the choice of the non-inferiority margin
-
-
-
4
-
-
84870858362
-
-
EMA/CHMP/BMWP/403543/2010. 30 May, homepage on the Internet]. 2012 June [cited 2014 Jan 23]. Available from
-
European Medicines Agency. Guideline on similar biological medicinal products containing monoclonal antibodies - non-clinical and clinical issues. EMA/CHMP/BMWP/403543/2010. 30 May 2012 [homepage on the Internet]. 2012 June [cited 2014 Jan 23]. Available from: http:// www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf
-
(2012)
Guideline on similar biological medicinal products containing monoclonal antibodies - non-clinical and clinical issues
-
-
-
6
-
-
84872403675
-
Statistical assessment of biosimilarity based on relative distance between follow-on biologics
-
Kang SH, Chow SC. Statistical assessment of biosimilarity based on relative distance between follow-on biologics. Statis Med. 2013;32(3):382-92.
-
(2013)
Statis Med.
, vol.32
, Issue.3
, pp. 382-392
-
-
Kang, S.H.1
Chow, S.C.2
-
7
-
-
0037231533
-
Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial
-
Weinblatt ME, Keystone EC, Furst DE, et al. Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum. 2003;48(1):35-45.
-
(2003)
Arthritis Rheum.
, vol.48
, Issue.1
, pp. 35-45
-
-
Weinblatt, M.E.1
Keystone, E.C.2
Furst, D.E.3
-
8
-
-
2342658406
-
Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human antitumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial
-
May
-
Keystone EC, Kavanaugh AF, Sharp JT, et al. Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human antitumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial. Arthritis Rheum. 2004 May;50(5):1400-11.
-
(2004)
Arthritis Rheum.
, vol.50
, Issue.5
, pp. 1400-1411
-
-
Keystone, E.C.1
Kavanaugh, A.F.2
Sharp, J.T.3
-
9
-
-
0348109372
-
Adalimumab, a fully human anti tumor necrosis factor-alpha monoclonal antibody, and concomitant standard antirheumatic therapy for the treatment of rheumatoid arthritis: results of STAR (Safety Trial of Adalimumab in Rheumatoid Arthritis)
-
Dec;
-
Furst DE, Schiff MH, Fleischmann RM, et al. Adalimumab, a fully human anti tumor necrosis factor-alpha monoclonal antibody, and concomitant standard antirheumatic therapy for the treatment of rheumatoid arthritis: results of STAR (Safety Trial of Adalimumab in Rheumatoid Arthritis). J Rheumatol. 2003 Dec;30(12):2563-71.
-
(2003)
J Rheumatol.
, vol.30
, Issue.12
, pp. 2563-2571
-
-
Furst, D.E.1
Schiff, M.H.2
Fleischmann, R.M.3
-
10
-
-
31044442965
-
The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment
-
Breedveld FC, Weisman, MH, Kavanaugh AF, et al. The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum. 2006;54(1):26-37.
-
(2006)
Arthritis Rheum.
, vol.54
, Issue.1
, pp. 26-37
-
-
Breedveld, F.C.1
Weisman, M.H.2
Kavanaugh, A.F.3
-
11
-
-
11144355274
-
Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed
-
van de Putte LB, Atkins C, Malaise M, et al. Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed. Ann Rheum Dis. 2004;63(5):508-16.
-
(2004)
Ann Rheum Dis.
, vol.63
, Issue.5
, pp. 508-516
-
-
van de Putte, L.B.1
Atkins, C.2
Malaise, M.3
-
12
-
-
77956266591
-
Treatment outcomes by tumor histology in Eastern Cooperative Group Study E4599 of bevacizumab with paclitaxel/carboplatin for advanced non-small cell lung cancer
-
Sandler A, Yi J, Dahlberg, et al. Treatment outcomes by tumor histology in Eastern Cooperative Group Study E4599 of bevacizumab with paclitaxel/carboplatin for advanced non-small cell lung cancer. J Thorac Oncol. 2010;5(9):1416-23.
-
(2010)
J Thorac Oncol.
, vol.5
, Issue.9
, pp. 1416-1423
-
-
Sandler, A.1
Yi, J.2
Dahlberg3
-
13
-
-
62449124416
-
Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAil
-
Reck M, von Pawel J, Zatloukal P, et al. Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAil. J Clin Oncol. 2009;27(8):1227-34.
-
(2009)
J Clin Oncol.
, vol.27
, Issue.8
, pp. 1227-1234
-
-
Reck, M.1
von Pawel, J.2
Zatloukal, P.3
-
14
-
-
85008254756
-
A novel approach to rituximab biosimilar drug development
-
Suppl; abstr e13064
-
Berry SM, Reitsma DJ, Combest AJ, et al. A novel approach to rituximab biosimilar drug development. J Clin Oncol. 2011:29(Suppl; abstr e13064).
-
(2011)
J Clin Oncol.
, vol.29
-
-
Berry, S.M.1
Reitsma, D.J.2
Combest, A.J.3
-
15
-
-
2542561964
-
Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer
-
Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004;350(23):2335-42.
-
(2004)
N Engl J Med.
, vol.350
, Issue.23
, pp. 2335-2342
-
-
Hurwitz, H.1
Fehrenbacher, L.2
Novotny, W.3
-
16
-
-
42949149159
-
Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study
-
Saltz LB, Clarke S, Díaz-Rubio E, et al. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol. 2008;26(12):2013-9.
-
(2008)
J Clin Oncol.
, vol.26
, Issue.12
, pp. 2013-2019
-
-
Saltz, L.B.1
Clarke, S.2
Díaz-Rubio, E.3
-
17
-
-
34248173883
-
Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200
-
Giantonio BJ, Catalano PJ, Meropol NJ, et al. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol. 2007;25(12):1539-44.
-
(2007)
J Clin Oncol.
, vol.25
, Issue.12
, pp. 1539-1544
-
-
Giantonio, B.J.1
Catalano, P.J.2
Meropol, N.J.3
-
18
-
-
73349120007
-
Independent review of E2100: a phase III trial of bevacizumab plus paclitaxel versus paclitaxel in women with metastatic breast cancer
-
Gray R, Bhattacharya S, Bowden C, et al. Independent review of E2100: a phase III trial of bevacizumab plus paclitaxel versus paclitaxel in women with metastatic breast cancer. J Clin Oncol. 2009;27(30):4966-72.
-
(2009)
J Clin Oncol
, vol.27
, Issue.30
, pp. 4966-4972
-
-
Gray, R.1
Bhattacharya, S.2
Bowden, C.3
-
19
-
-
77954700380
-
Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer
-
Miles DW, Chan A, Dirix LY, et al. Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2010;28(20):3239-47.
-
(2010)
J Clin Oncol.
, vol.28
, Issue.20
, pp. 3239-3247
-
-
Miles, D.W.1
Chan, A.2
Dirix, L.Y.3
-
20
-
-
70350461699
-
Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma
-
Friedman HS, Prados MD, Wen PY, et al. Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma. J Clin Oncol. 2009;27(28):4733-40.
-
(2009)
J Clin Oncol.
, vol.27
, Issue.28
, pp. 4733-4740
-
-
Friedman, H.S.1
Prados, M.D.2
Wen, P.Y.3
-
21
-
-
37349080670
-
Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial
-
Escudier B, Pluzanska A, Koralewski P, et al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet. 2007;370(9605):2103-11.
-
(2007)
Lancet.
, vol.370
, Issue.9605
, pp. 2103-2111
-
-
Escudier, B.1
Pluzanska, A.2
Koralewski, P.3
-
22
-
-
84855425106
-
Incorporation of bevacizumab in the primary treatment of ovarian cancer
-
Burger RA, Brady MF, Bookman MA, et al. Incorporation of bevacizumab in the primary treatment of ovarian cancer. N Engl J Med. 2011; 365(26):2473-83.
-
(2011)
N Engl J Med.
, vol.365
, Issue.26
, pp. 2473-2483
-
-
Burger, R.A.1
Brady, M.F.2
Bookman, M.A.3
-
23
-
-
84875248912
-
Standard chemotherapy with or without bevacizumab in advanced ovarian cancer: qualityof- life outcomes from the International Collaboration on Ovarian Neoplasms (ICON7) phase 3 randomised trial
-
Stark D, Nankivell M, Pujade-Lauraine E, et al. Standard chemotherapy with or without bevacizumab in advanced ovarian cancer: qualityof- life outcomes from the International Collaboration on Ovarian Neoplasms (ICON7) phase 3 randomised trial. Lancet Oncol. 2013;14(3):236-43.
-
(2013)
Lancet Oncol.
, vol.14
, Issue.3
, pp. 236-243
-
-
Stark, D.1
Nankivell, M.2
Pujade-Lauraine, E.3
-
24
-
-
84861736119
-
OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer
-
Aghajanian C, Blank SV, Goff BA, et al. OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol. 2012;30(17):2039-45.
-
(2012)
J Clin Oncol.
, vol.30
, Issue.17
, pp. 2039-2045
-
-
Aghajanian, C.1
Blank, S.V.2
Goff, B.A.3
|