-
1
-
-
84995719993
-
-
European Medicines Agency. Guideline on Similar Biological Medicinal Products.. Accessed June 5
-
European Medicines Agency. Guideline on Similar Biological Medicinal Products. Available at: http://www.ema. europa.eu/docs/en-GB/document-library/Scientific- guideline/2014/10/WC500176768.pdf. Accessed June 5, 2015.
-
(2015)
-
-
-
2
-
-
84995716635
-
-
U.S. Food and Drug Administration. Guidance for Industry: Scientific Considerations inDemonstrating Biosimilarity to a Reference Product. Draft Guidelines. U.S. Department of Health and Human Services Food and Drug Administration; 2015. Available at:. Accessed April 7
-
U.S. Food and Drug Administration. Guidance for Industry: Scientific Considerations inDemonstrating Biosimilarity to a Reference Product. Draft Guidelines. U.S. Department of Health and Human Services Food and Drug Administration; 2015. Available at: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ UCM291128.pdf. Accessed April 7, 2015.
-
(2015)
-
-
-
3
-
-
84995712740
-
-
World Health Organization. Accessed April 7
-
World Health Organization. Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). Available at: http:// www.who.int/biologicals/areas/biological-therapeutics/ BIOTHERAPEUTICS-FOR-WEB-22APRIL2010.pdf. Accessed April 7, 2015.
-
(2015)
Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs)
-
-
-
4
-
-
84995724128
-
Development of statistical methods for analytical similarity assessment
-
Sep 15. Epub ahead of print
-
Tsong Y, Dong X, Shen M. Development of statistical methods for analytical similarity assessment. J Biopharm Stat. 2015 Sep 15. [Epub ahead of print].
-
(2015)
J Biopharm Stat
-
-
Tsong, Y.1
Dong, X.2
Shen, M.3
-
5
-
-
84995730369
-
-
U.S. Food and Drug Administration. Guidance for Industry E9 Statistical Principles for Clinical Trials. U.S. Department of Health and Human Services Food and Drug Administration. Accessed July 1, 2015
-
U.S. Food and Drug Administration. Guidance for Industry E9 Statistical Principles for Clinical Trials. U.S. Department of Health and Human Services Food and Drug Administration; 1998. Available at: http://www.fda.gov/downloads/ drugs/guidancecomplianceregulatoryinformation/ guidances/ucm073137.pdf. Accessed July 1, 2015.
-
(1998)
-
-
-
6
-
-
78751567912
-
Understanding equivalence and noninferiority testing
-
Walker E, Nowacki AS. Understanding equivalence and noninferiority testing. J Gen Intern Med. 2011;26:192-196.
-
(2011)
J Gen Intern Med
, vol.26
, pp. 192-196
-
-
Walker, E.1
Nowacki, A.S.2
-
8
-
-
80053562561
-
Statistical considerations for confirmatory clinical trials for similar biotherapeutic products
-
Njue C. Statistical considerations for confirmatory clinical trials for similar biotherapeutic products. Biologicals. 2011;39:266-269.
-
(2011)
Biologicals
, vol.39
, pp. 266-269
-
-
Njue, C.1
-
9
-
-
84995713667
-
-
SAS Institute Inc. SAS/STAT 9.2 User's Guide. TOST Equivalence Test. 2nd ed.. Accessed July 2
-
SAS Institute Inc. SAS/STAT 9.2 User's Guide. TOST Equivalence Test. 2nd ed. Available at: http://support. sas.com/documentation/cdl/en/statug/63033/HTML/ default/viewer.htm#statug-ttest-a0000000128.htm. Accessed July 2, 2015.
-
(2015)
-
-
-
10
-
-
84995727266
-
-
United States Food and Drug Administration. Guidance for Industry Non-Inferiority Clinical Trials. Draft Guidance. Available at:. Accessed September 24
-
United States Food and Drug Administration. Guidance for Industry Non-Inferiority Clinical Trials. Draft Guidance. Available at: http://www.fda.gov/downloads/ Drugs/./Guidances/UCM202140.pdf. Accessed September 24, 2015.
-
(2015)
-
-
-
11
-
-
84995727265
-
-
SAS Institute Inc. SAS/STAT 9.2 User's Guide [computer Program]. Version 2. SAS Institute Inc., Cary, NC; 2010
-
SAS Institute Inc. SAS/STAT 9.2 User's Guide [computer Program]. Version 2. SAS Institute Inc., Cary, NC; 2010.
-
-
-
-
12
-
-
75649146954
-
Statistical assessment of biosimilar products
-
Chow SC, Liu JP. Statistical assessment of biosimilar products. J Biopharm Stat. 2010;20:10-30.
-
(2010)
J Biopharm Stat
, vol.20
, pp. 10-30
-
-
Chow, S.C.1
Liu, J.P.2
-
13
-
-
84995716577
-
-
U.S. Food and Drug Administration. Guidance for Industry Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product. Draft Guidance. U.S. Department of Health and Human Services Food and Drug Administration. Accessed July 1, 2015
-
U.S. Food and Drug Administration. Guidance for Industry Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product. Draft Guidance. U.S. Department of Health and Human Services Food and Drug Administration; 2014. Available at: http://www. fda.gov/downloads/drugs/guidancecomplianceregula toryinformation/guidances/ucm397017.pdf. Accessed July 1, 2015.
-
(2014)
-
-
-
14
-
-
34748833984
-
Measures of effect: Relative risks, odds ratios, risk difference, and number needed to treat
-
Tripepi G, Jager KJ, Dekker FW, et al. Measures of effect: relative risks, odds ratios, risk difference, and number needed to treat. Kidney Int. 2007;72:789-791.
-
(2007)
Kidney Int
, vol.72
, pp. 789-791
-
-
Tripepi, G.1
Jager, K.J.2
Dekker, F.W.3
-
15
-
-
84995713171
-
-
U.S. Food and Drug Administration. Guidance for Industry Statistical Approaches to Establishing Bioequivalence. U. S. Department of Health and Human Services Food and Drug Administration. Accessed July 1, 2015
-
U.S. Food and Drug Administration. Guidance for Industry Statistical Approaches to Establishing Bioequivalence. U. S. Department of Health and Human Services Food and Drug Administration; 2001. Available at: http://www. fda.gov/downloads/drugs/guidancecomplianceregula toryinformation/guidances/ucm070244.pdf. Accessed July 1, 2015.
-
(2001)
-
-
-
16
-
-
81255204165
-
Intention-to-treat concept: A review
-
Gupta SK. Intention-to-treat concept: a review. Perspect Clin Res. 2011;2:109-112.
-
(2011)
Perspect Clin Res
, vol.2
, pp. 109-112
-
-
Gupta, S.K.1
-
17
-
-
80052607351
-
Efficacy of bevacizumab (Bev) plus chemotherapy (CT) compared to CT alone in previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC): Systematic review and meta-analysis
-
Botrel TE, Clark O, Clark L, et al. Efficacy of bevacizumab (Bev) plus chemotherapy (CT) compared to CT alone in previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC): systematic review and meta-analysis. Lung Cancer. 2011;74:89-97.
-
(2011)
Lung Cancer
, vol.74
, pp. 89-97
-
-
Botrel, T.E.1
Clark, O.2
Clark, L.3
-
18
-
-
84995730345
-
-
Genentech Inc. Avastin (Bevacizumab) Prescribing Information. South San Francisco, CA. Accessed September 4
-
Genentech Inc. Avastin (Bevacizumab) Prescribing Information. South San Francisco, CA. Available at: http:// www.gene.com/download/pdf/avastin-prescribing. pdf. Accessed September 4, 2015.
-
(2015)
-
-
-
19
-
-
84995716605
-
-
Roche. Summary of Product Characteristics. Avastin (Bevacizumab). Available at:. Accessed September 4
-
Roche. Summary of Product Characteristics. Avastin (Bevacizumab). Available at: http://www.ema.europa.eu/docs/en- GB/document-library/EPAR-Product-Information/ human/000582/WC500029271.pdf. Accessed September 4, 2015.
-
(2015)
-
-
-
20
-
-
84924733846
-
Clinical considerations for the development of biosimilars in oncology
-
Socinski MA, Curigliano G, Jacobs I, et al. Clinical considerations for the development of biosimilars in oncology. MAbs. 2015;7:286-293.
-
(2015)
MAbs
, vol.7
, pp. 286-293
-
-
Socinski, M.A.1
Curigliano, G.2
Jacobs, I.3
-
21
-
-
84995722861
-
-
European Medicines Agency. Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins. Available at:. Accessed July 15
-
European Medicines Agency. Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins. Available at: http://www.ema.europa.eu/docs/ en-GB/document-library/Scientific-guideline/2009/ 09/WC500003946.pdf. Accessed July 15, 2015.
-
(2015)
-
-
-
22
-
-
2942657615
-
Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic nonsmall-cell lung cancer
-
Johnson DH, Fehrenbacher L, Novotny WF, et al. Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic nonsmall-cell lung cancer. J Clin Oncol. 2004;22:2184-2191.
-
(2004)
J Clin Oncol
, vol.22
, pp. 2184-2191
-
-
Johnson, D.H.1
Fehrenbacher, L.2
Novotny, W.F.3
-
23
-
-
84860505684
-
Randomized phase II study of first-line carboplatin-paclitaxel with or without bevacizumab in Japanese patients with advanced non-squamous non-small-cell lung cancer
-
Niho S, Kunitoh H, Nokihara H, et al. Randomized phase II study of first-line carboplatin-paclitaxel with or without bevacizumab in Japanese patients with advanced non-squamous non-small-cell lung cancer. Lung Cancer. 2012;76:362-367.
-
(2012)
Lung Cancer
, vol.76
, pp. 362-367
-
-
Niho, S.1
Kunitoh, H.2
Nokihara, H.3
-
24
-
-
77951473661
-
Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: Results from a randomised phase III trial (AVAiL)
-
Reck M, von Pawel J, Zatloukal P, et al. Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial (AVAiL). Ann Oncol. 2010;21:1804-1809.
-
(2010)
Ann Oncol
, vol.21
, pp. 1804-1809
-
-
Reck, M.1
Von Pawel, J.2
Zatloukal, P.3
-
25
-
-
33845490014
-
Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer
-
Sandler A, Gray R, Perry MC, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006;355:2542-2550.
-
(2006)
N Engl J Med
, vol.355
, pp. 2542-2550
-
-
Sandler, A.1
Gray, R.2
Perry, M.C.3
-
26
-
-
33746961890
-
Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks
-
Cohen SB, Emery P, Greenwald MW, et al. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum. 2006;54:2793-2806.
-
(2006)
Arthritis Rheum
, vol.54
, pp. 2793-2806
-
-
Cohen, S.B.1
Emery, P.2
Greenwald, M.W.3
-
27
-
-
65249186690
-
Evaluation of different methods used to assess disease activity in rheumatoid arthritis: Analyses of abatacept clinical trial data
-
Dougados M, Schmidely N, Le Bars M, et al. Evaluation of different methods used to assess disease activity in rheumatoid arthritis: analyses of abatacept clinical trial data. Ann Rheum Dis. 2009;68:484-489.
-
(2009)
Ann Rheum Dis
, vol.68
, pp. 484-489
-
-
Dougados, M.1
Schmidely, N.2
Le Bars, M.3
-
28
-
-
2942537697
-
Efficacy of B-cell-targeted therapy with rituximab in patients with rheumatoid arthritis
-
Edwards JC, Szczepanski L, Szechinski J, et al. Efficacy of B-cell-targeted therapy with rituximab in patients with rheumatoid arthritis. N Engl J Med. 2004;350:2572-2581.
-
(2004)
N Engl J Med
, vol.350
, pp. 2572-2581
-
-
Edwards, J.C.1
Szczepanski, L.2
Szechinski, J.3
-
29
-
-
77955896561
-
Efficacy and safety of different doses and retreatment of rituximab: A randomised, placebo-controlled trial in patients who are biological naive with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab's Efficacy in MTX iNadequate rEsponders (SERENE))
-
Emery P, Deodhar A, Rigby WF, et al. Efficacy and safety of different doses and retreatment of rituximab: a randomised, placebo-controlled trial in patients who are biological naive with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab's Efficacy in MTX iNadequate rEsponders (SERENE)). Ann Rheum Dis. 2010;69: 1629-1635.
-
(2010)
Ann Rheum Dis
, vol.69
, pp. 1629-1635
-
-
Emery, P.1
Deodhar, A.2
Rigby, W.F.3
-
30
-
-
33646483031
-
The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: Results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial
-
Emery P, Fleischmann R, Filipowicz-Sosnowska A, et al. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial. Arthritis Rheum. 2006;54:1390-1400.
-
(2006)
Arthritis Rheum
, vol.54
, pp. 1390-1400
-
-
Emery, P.1
Fleischmann, R.2
Filipowicz-Sosnowska, A.3
-
31
-
-
33644790320
-
The disease activity score and the EULAR response criteria
-
Fransen J, van Riel PL. The disease activity score and the EULAR response criteria. Clin Exp Rheumatol. 2005;23: S93-S99.
-
(2005)
Clin Exp Rheumatol
, vol.23
, pp. S93-S99
-
-
Fransen, J.1
Van Riel, P.L.2
-
32
-
-
77957137728
-
Rituximab for rheumatoid arthritis: A meta-analysis and systematic review
-
Volkmann E, Agrawal H, Maranian P, et al. Rituximab for rheumatoid arthritis: a meta-analysis and systematic review. Clin Med Insights. 2010;2:749-760.
-
(2010)
Clin Med Insights
, vol.2
, pp. 749-760
-
-
Volkmann, E.1
Agrawal, H.2
Maranian, P.3
-
33
-
-
84857801361
-
Evaluating disease activity in rheumatoid arthritis: Which composite index is best? A systematic literature analysis of studies comparing the psychometric properties of the DAS, DAS28, SDAI and CDAI
-
Gaujoux-Viala C, Mouterde G, Baillet A, et al. Evaluating disease activity in rheumatoid arthritis: which composite index is best? A systematic literature analysis of studies comparing the psychometric properties of the DAS, DAS28, SDAI and CDAI. Joint Bone Spine. 2012; 79:149-155.
-
(2012)
Joint Bone Spine
, vol.79
, pp. 149-155
-
-
Gaujoux-Viala, C.1
Mouterde, G.2
Baillet, A.3
|