-
1
-
-
84892899816
-
Evolution of clinical trial design in early drug development: Systemic review of expansion cohort use in single-agent phase i cancer trials
-
Manji A, Brana E, Amir E, Tomlinson G, Tannock IF, Beddard PL, et al. Evolution of clinical trial design in early drug development: systemic review of expansion cohort use in single-agent phase I cancer trials. J Clin Oncol 2013;31:4260-7.
-
(2013)
J Clin Oncol
, vol.31
, pp. 4260-4267
-
-
Manji, A.1
Brana, E.2
Amir, E.3
Tomlinson, G.4
Tannock, I.F.5
Beddard, P.L.6
-
2
-
-
84880470045
-
Genomic medicine frontier in human solid tumors: Prospects and challenges
-
Dienstmann R, Rodon J, Barretina J, Tabernero J. Genomic medicine frontier in human solid tumors: prospects and challenges. J Clin Oncol 2013;31:1874-84.
-
(2013)
J Clin Oncol
, vol.31
, pp. 1874-1884
-
-
Dienstmann, R.1
Rodon, J.2
Barretina, J.3
Tabernero, J.4
-
3
-
-
84880706152
-
Oncology meets immunology: The cancer-immunity cycle
-
Chen SD, Melman I. Oncology meets immunology: the cancer-immunity cycle. Immunity 2013;39:1-10.
-
(2013)
Immunity
, vol.39
, pp. 1-10
-
-
Chen, S.D.1
Melman, I.2
-
5
-
-
84945560955
-
-
[PDF on the Internet]. Geneva (Switzerland): The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH); [cited 2015 Aug 12]. Available from
-
ICHharmonised tripartite guideline: general considerations for clinical trials (E8) [PDF on the Internet]. Geneva (Switzerland): The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH); 1997 [cited 2015 Aug 12]. Available from: http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Efficacy/E8/Step4/E8-Guideline.pdf.
-
(1997)
ICHharmonised Tripartite Guideline: General Considerations for Clinical Trials (E8)
-
-
-
6
-
-
0034106330
-
Current definitions of phases of investigation and the role of the FDA in the conduct of clinical trials
-
Temple R. Current definitions of phases of investigation and the role of the FDA in the conduct of clinical trials. Am Heart J 2000;139: S133-5.
-
(2000)
Am Heart J
, vol.139
, pp. S133-S135
-
-
Temple, R.1
-
8
-
-
84905216493
-
Evaluation of statistical designs in phase i expansion cohorts: The Dana-Farber/Harvard Cancer Center experience
-
Dahlberg SE, Shapiro GI, Clark JW, Johnson BE. Evaluation of statistical designs in phase I expansion cohorts: the Dana-Farber/Harvard Cancer Center experience. J Natl Cancer Inst 2014;106:1-7.
-
(2014)
J Natl Cancer Inst
, vol.106
, pp. 1-7
-
-
Dahlberg, S.E.1
Shapiro, G.I.2
Clark, J.W.3
Johnson, B.E.4
-
9
-
-
84904006604
-
-
[PDF on the Internet]. Silver Spring (MD): U.S. Food and Drug Administration; [cited 2015 Aug 12]. Available from
-
Guidance for industry: expedited programs for serious conditions-drugs and biologics [PDF on the Internet]. Silver Spring (MD): U.S. Food and Drug Administration; 2014 [cited 2015 Aug 12]. Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf.
-
(2014)
Guidance for Industry: Expedited Programs for Serious Conditions-drugs and Biologics
-
-
-
10
-
-
84945579041
-
Good review practice: Management of Breakthrough Therapy-designated drugs and biologics
-
[PDF on the Internet] Silver Spring (MD): U.S. Food and Drug Administration, Office of New Drugs; [cited 2015 Aug 1]. Available from
-
Good review practice: management of Breakthrough Therapy-designated drugs and biologics [PDF on the Internet]. In: Manual of policies and procedure, Center forDrug Evaluation and Research (MAPP6025.6). Silver Spring (MD): U.S. Food and Drug Administration, Office of New Drugs; 2014 [cited 2015 Aug 1]. Available from: http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM407009.pdf.
-
(2014)
Manual of Policies and Procedure, Center ForDrug Evaluation and Research (MAPP6025.6)
-
-
-
11
-
-
84908354848
-
Antiprogrammed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: A randomised dose-comparison cohort of a phase 1 trial
-
Robert C, Ribas A, Wolchok JD, Hodi FS, Hamid O, Kefford R, et al. Antiprogrammed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial. Lancet 2014;384:1109-17.
-
(2014)
Lancet
, vol.384
, pp. 1109-1117
-
-
Robert, C.1
Ribas, A.2
Wolchok, J.D.3
Hodi, F.S.4
Hamid, O.5
Kefford, R.6
-
12
-
-
77955798710
-
-
[database on the Internet]. Silver Spring (MD): U.S. Food and Drug Administration; [cited 2015Aug 1]. Summary review; reference ID: 3621254 Available from: Files updated daily
-
Drugs@FDA [database on the Internet]. Silver Spring (MD): U.S. Food and Drug Administration; 2014[cited 2015Aug 1]. Summary review; reference ID: 3621254 [about 22 p.]. Available from: http://www.accessdata.fda.gov/drugsatfda-docs/nda/2014/125514Orig1s000SumR.pdf. Files updated daily.
-
(2014)
Drugs@FDA
-
-
-
14
-
-
84929481480
-
Pembrolizumab for the treatment of non-small-cell lung cancer
-
Garon EB, Rizvi NA, Hui R, Leighl N, Balmanoukian AS, Eder JP, et al. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med 2015;372:2018-28.
-
(2015)
N Engl J Med
, vol.372
, pp. 2018-2028
-
-
Garon, E.B.1
Rizvi, N.A.2
Hui, R.3
Leighl, N.4
Balmanoukian, A.S.5
Eder, J.P.6
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