-
1
-
-
79959476700
-
The evolution of protein kinase inhibitors from antagonists to agonists of cellular signaling
-
Dar AC,Shokat KM.The evolution of protein kinase inhibitors from antagonists to agonists of cellular signaling.Annu Rev Biochem. 2011;80:769-795.
-
(2011)
Annu Rev Biochem
, vol.80
, pp. 769-795
-
-
Dar, A.C.1
Shokat, K.M.2
-
2
-
-
75649145389
-
Combining targeted therapies: practical issues to consider at the bench and bedside
-
Rodon J,Perez J,Kurzrock R.Combining targeted therapies: practical issues to consider at the bench and bedside.Oncologist. 2010;15 (1): 37-50.
-
(2010)
Oncologist
, vol.15
, Issue.1
, pp. 37-50
-
-
Rodon, J.1
Perez, J.2
Kurzrock, R.3
-
3
-
-
48249137667
-
Therapeutic potential of novel selective-spectrum kinase inhibitors in oncology
-
Lorusso PM,Eder JP.Therapeutic potential of novel selective-spectrum kinase inhibitors in oncology.Expert Opin Investig Drugs. 2008;17 (7): 1013-1028.
-
(2008)
Expert Opin Investig Drugs
, vol.17
, Issue.7
, pp. 1013-1028
-
-
Lorusso, P.M.1
Eder, J.P.2
-
4
-
-
67651216410
-
Next generation oncology drug development: opportunities and challenges
-
Gutierrez ME,Kummar S,Giaccone G.Next generation oncology drug development: opportunities and challenges.Nat Rev Clin Oncol. 2009;6 (5): 259-265.
-
(2009)
Nat Rev Clin Oncol
, vol.6
, Issue.5
, pp. 259-265
-
-
Gutierrez, M.E.1
Kummar, S.2
Giaccone, G.3
-
5
-
-
84861729659
-
Personalized medicine: striding from genes to medicines
-
Nair SR.Personalized medicine: striding from genes to medicines.Perspect Clin Res. 2010;1 (4): 146-150.
-
(2010)
Perspect Clin Res
, vol.1
, Issue.4
, pp. 146-150
-
-
Nair, S.R.1
-
6
-
-
80055036400
-
Biomarkers in tumor angiogenesis and anti-angiogenic therapy
-
Pircher A,Hilbe W,Heidegger I,Drevs J,Tichelli A,Medinger M.Biomarkers in tumor angiogenesis and anti-angiogenic therapy.Int J Mol Sci. 2011;12 (10): 7077-7099.
-
(2011)
Int J Mol Sci
, vol.12
, Issue.10
, pp. 7077-7099
-
-
Pircher, A.1
Hilbe, W.2
Heidegger, I.3
Drevs, J.4
Tichelli, A.5
Medinger, M.6
-
7
-
-
78149249388
-
Personalized medicine in non-small-cell lung cancer: is KRAS a useful marker in selecting patients for epidermal growth factor receptor-targeted therapy?
-
Roberts PJ,Stinchcombe TE,Der CJ,Socinski MA.Personalized medicine in non-small-cell lung cancer: is KRAS a useful marker in selecting patients for epidermal growth factor receptor-targeted therapy?.J Clin Oncol. 2010;28 (31): 4769-4777.
-
(2010)
J Clin Oncol
, vol.28
, Issue.31
, pp. 4769-4777
-
-
Roberts, P.J.1
Stinchcombe, T.E.2
Der, C.J.3
Socinski, M.A.4
-
8
-
-
79958815219
-
Cancer biomarkers, companion diagnostics and personalized oncology
-
Ross JS.Cancer biomarkers, companion diagnostics and personalized oncology.Biomark Med. 2011;5 (3): 277-279.
-
(2011)
Biomark Med
, vol.5
, Issue.3
, pp. 277-279
-
-
Ross, J.S.1
-
9
-
-
80053085299
-
From the bench to bedside: biological and methodology considerations for the future of companion diagnostics in nonsmall cell lung cancer
-
Dimou A,Harrington K,Syrigos KN.From the bench to bedside: biological and methodology considerations for the future of companion diagnostics in nonsmall cell lung cancer.Patholog Res Int. 2011;:312346.
-
(2011)
Patholog Res Int
, pp. 312346
-
-
Dimou, A.1
Harrington, K.2
Syrigos, K.N.3
-
10
-
-
84859412054
-
Comprehensive predictive biomarker analysis for MEK inhibitor GSK1120212
-
Jing J,Greshock J,Holbrook JD, et al.Comprehensive predictive biomarker analysis for MEK inhibitor GSK1120212.Mol Cancer Ther. 2012;11 (3): 720-729.
-
(2012)
Mol Cancer Ther
, vol.11
, Issue.3
, pp. 720-729
-
-
Jing, J.1
Greshock, J.2
Holbrook, J.D.3
-
11
-
-
70350163204
-
Biomarker-driven early clinical trials in oncology: a paradigm shift in drug development
-
Tan DS,Thomas GV,Garrett MD, et al.Biomarker-driven early clinical trials in oncology: a paradigm shift in drug development.Cancer J. 2009;15 (5): 406-420.
-
(2009)
Cancer J
, vol.15
, Issue.5
, pp. 406-420
-
-
Tan, D.S.1
Thomas, G.V.2
Garrett, M.D.3
-
12
-
-
67349111010
-
Predictive biomarkers in the development of oncology drugs: a therapeutic industry perspective
-
Fine BM,Amler L.Predictive biomarkers in the development of oncology drugs: a therapeutic industry perspective.Clin Pharmacol Ther. 2009;85 (5): 535-538.
-
(2009)
Clin Pharmacol Ther
, vol.85
, Issue.5
, pp. 535-538
-
-
Fine, B.M.1
Amler, L.2
-
13
-
-
69949102133
-
Confirmatory adaptive designs with Bayesian decision tools for a targeted therapy in oncology
-
Brannath W,Zuber E,Branson M, et al.Confirmatory adaptive designs with Bayesian decision tools for a targeted therapy in oncology.Stat Med. 2009;28 (10): 1445-1463.
-
(2009)
Stat Med
, vol.28
, Issue.10
, pp. 1445-1463
-
-
Brannath, W.1
Zuber, E.2
Branson, M.3
-
14
-
-
78649956851
-
Bayesian adaptive randomization designs for targeted agent development
-
Lee JJ,Gu X,Liu S.Bayesian adaptive randomization designs for targeted agent development.Clin Trials. 2010;7 (5): 584-596.
-
(2010)
Clin Trials
, vol.7
, Issue.5
, pp. 584-596
-
-
Lee, J.J.1
Gu, X.2
Liu, S.3
-
15
-
-
79952079839
-
Adaptive clinical trials: the promise and the caution
-
Berry DA.Adaptive clinical trials: the promise and the caution.J Clin Oncol. 2011;29 (6): 606-609.
-
(2011)
J Clin Oncol
, vol.29
, Issue.6
, pp. 606-609
-
-
Berry, D.A.1
-
16
-
-
66349125688
-
Adaptive patient enrichment designs in therapeutic trials
-
Wang SJ,Hung HM,O'Neill RT.Adaptive patient enrichment designs in therapeutic trials.Biom J. 2009;51 (2): 358-374.
-
(2009)
Biom J
, vol.51
, Issue.2
, pp. 358-374
-
-
Wang, S.J.1
Hung, H.M.2
O'Neill, R.T.3
-
17
-
-
84857534782
-
Design issues in randomized phase II/III trials
-
Korn EL,Freidlin B,Abrams JS,Halabi S.Design issues in randomized phase II/III trials. J Clin Oncol. 2012;30 (6): 667-671.
-
(2012)
J Clin Oncol
, vol.30
, Issue.6
, pp. 667-671
-
-
Korn, E.L.1
Freidlin, B.2
Abrams, J.S.3
Halabi, S.4
-
18
-
-
84858864380
-
Bayesian adaptive trial design for a newly validated surrogate endpoint
-
Renfro LA,Carlin BP,Sargent DJ.Bayesian adaptive trial design for a newly validated surrogate endpoint. Biometrics. 2012;68 (1): 258-267.
-
(2012)
Biometrics
, vol.68
, Issue.1
, pp. 258-267
-
-
Renfro, L.A.1
Carlin, B.P.2
Sargent, D.J.3
-
19
-
-
26044449076
-
The FDA's new oncology office
-
Pazdur R.The FDA's new oncology office.Clin Adv Hematol Oncol. 2005;3 (8): 612-613.
-
(2005)
Clin Adv Hematol Oncol
, vol.3
, Issue.8
, pp. 612-613
-
-
Pazdur, R.1
-
20
-
-
79952113574
-
The Vioxx pharmaceutical scandal
-
Faunce T,Townsend R,McEwan A.The Vioxx pharmaceutical scandal.J Law Med. 2010;18 (1): 38-49.
-
(2010)
J Law Med
, vol.18
, Issue.1
, pp. 38-49
-
-
Faunce, T.1
Townsend, R.2
McEwan, A.3
-
21
-
-
78049471936
-
Suspension of the commercialization of sibutramine and rosiglitazone in Europe
-
Scheen AJ.Suspension of the commercialization of sibutramine and rosiglitazone in Europe.Rev Med Liege. 2010;65 (10): 574-579.
-
(2010)
Rev Med Liege
, vol.65
, Issue.10
, pp. 574-579
-
-
Scheen, A.J.1
-
23
-
-
80052643571
-
Biotech reviews: keeping up with current developments
-
Hober S.Biotech reviews: keeping up with current developments.Biotechnol J. 2011;6 (9): 1031.
-
(2011)
Biotechnol J
, vol.6
, Issue.9
, pp. 1031
-
-
Hober, S.1
-
24
-
-
84864818051
-
Biotech industry highlights
-
Biotech industry highlights.Biotechnol J. 2011;6 (12): 1433-1434.
-
(2011)
Biotechnol J
, vol.6
, Issue.12
, pp. 1433-1434
-
-
-
25
-
-
77949374910
-
Biotech research: bringing better therapies to the people
-
Heinzelmann E.Biotech research: bringing better therapies to the people.Chimia (Aarau). 2010;64 (1-2): 91-93.
-
(2010)
Chimia (Aarau)
, vol.64
, Issue.1-2
, pp. 91-93
-
-
Heinzelmann, E.1
-
26
-
-
73649110241
-
From cancer alley to biotech: the importance of mentors
-
Azare J.From cancer alley to biotech: the importance of mentors.J Cancer Educ. 2009;24 (Suppl 2): S71-S72.
-
(2009)
J Cancer Educ
, vol.24
, Issue.SUPPL. 2
-
-
Azare, J.1
-
27
-
-
52949122846
-
Monoclonal antibodies come of age
-
Ledford H.Monoclonal antibodies come of age.Nature. 2008;455 (7212): 437.
-
(2008)
Nature
, vol.455
, Issue.7212
, pp. 437
-
-
Ledford, H.1
-
28
-
-
84874542763
-
-
Food and Drug Administration. Available at. Accessed January 2
-
Food and Drug Administration. NME drug and new biologic approvals. Available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/ucm121136.htm. Accessed January 2, 2012.
-
(2012)
NME drug and new biologic approvals
-
-
-
29
-
-
73649119080
-
-
Food and Drug Administration. Available at. Accessed January 2
-
Food and Drug Administration. What's new from the Office of Oncology Drug Products. Available at: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm093885.htm. Accessed January 2, 2012.
-
(2012)
What's new from the Office of Oncology Drug Products
-
-
-
30
-
-
79955445696
-
Accelerated approval of oncology products: the Food and Drug Administration experience
-
Johnson JR,Ning YM,Farrell A,Justice R,Keegan P,Pazdur R.Accelerated approval of oncology products: the Food and Drug Administration experience.J Natl Cancer Inst. 2011;103 (8): 636-644.
-
(2011)
J Natl Cancer Inst
, vol.103
, Issue.8
, pp. 636-644
-
-
Johnson, J.R.1
Ning, Y.M.2
Farrell, A.3
Justice, R.4
Keegan, P.5
Pazdur, R.6
-
31
-
-
77649244511
-
Review of oncology and hematology drug product approvals at the US FDA between July 2005 and December 2007
-
Sridhara R,Johnson JR,Justice R,Keegan P,Chakravarty A,Pazdur R.Review of oncology and hematology drug product approvals at the US FDA between July 2005 and December 2007.J Natl Cancer Inst. 2010;102 (4): 230-243.
-
(2010)
J Natl Cancer Inst
, vol.102
, Issue.4
, pp. 230-243
-
-
Sridhara, R.1
Johnson, J.R.2
Justice, R.3
Keegan, P.4
Chakravarty, A.5
Pazdur, R.6
-
32
-
-
84864797589
-
-
Center Watch. Available at. Accessed January 2
-
Center Watch. FDA approved drugs for oncology. Available at: http://www.centerwatch.com/drug-information/fda-approvals/drug-areas.aspx?AreaID=12. Accessed January 2, 2012.
-
(2012)
FDA approved drugs for oncology
-
-
-
33
-
-
84864823352
-
-
The Pink Sheet Web site. Accessed January 2
-
The Pink Sheet Web site. http://thepinksheet.elsevierbi.com. Accessed January 2, 2012.
-
(2012)
-
-
-
35
-
-
59949091448
-
Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer
-
Bokemeyer C,Bondarenko I,Makhson A, et al.Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer.J Clin Oncol. 2009;27 (5): 663-671.
-
(2009)
J Clin Oncol
, vol.27
, Issue.5
, pp. 663-671
-
-
Bokemeyer, C.1
Bondarenko, I.2
Makhson, A.3
-
36
-
-
63849088630
-
Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer
-
Van Cutsem E,Köhne CH,Hitre E, et al.Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer.N Eng J Med. 2009;360 (14): 1408-1417.
-
(2009)
N Eng J Med
, vol.360
, Issue.14
, pp. 1408-1417
-
-
van Cutsem, E.1
Köhne, C.H.2
Hitre, E.3
-
37
-
-
79954554297
-
Predictive molecular markers of response to epidermal growth factor receptor(EGFR) family-targeted therapies
-
Barton S,Starling N,Swanton C.Predictive molecular markers of response to epidermal growth factor receptor(EGFR) family-targeted therapies.Curr Cancer Drug Targets. 2010;10 (8): 799-812.
-
(2010)
Curr Cancer Drug Targets
, vol.10
, Issue.8
, pp. 799-812
-
-
Barton, S.1
Starling, N.2
Swanton, C.3
-
40
-
-
84864815433
-
-
clinical Trials, Available at, Accessed January 2
-
Clinical Trials. A study of GSK2118436 in BRAF mutant metastatic melanoma to the brain. Available at: http://clinicaltrials.gov/ct2/show/NCT01266967? term=GSK2118436+biomarker&rank=2. Accessed January 2, 2012.
-
(2012)
A study of GSK2118436 in BRAF mutant metastatic melanoma to the brain
-
-
-
41
-
-
84871289854
-
-
Available at, Accessed January 2, 2012
-
Personalized Medicine Coalition. Policy. Available at: http://www.personalizedmedicinecoalition.org/policy. Accessed January 2, 2012.
-
Personalized Medicine Coalition. Policy
-
-
-
42
-
-
84864819032
-
Code of Federal Regulations
-
Title 21, 314.126: adequate and well-controlled studies (21CFR314.126). Available at, Accessed January 2, 2012
-
Code of Federal Regulations. 2010, Title 21, Volume 5, Part 314. Applications for FDA approval to market a new drug, subpart D: FDA action on applications and abbreviated applications. Sec. 314.126: adequate and well-controlled studies (21CFR314.126). Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.126. Accessed January 2, 2012.
-
(2010)
Applications for FDA approval to market a new drug, subpart D: FDA action on applications and abbreviated applications. Sec.
, vol.21
, Issue.PART 314
-
-
-
43
-
-
0003875318
-
-
European Medicines Agency Available at, Accessed January 2, 2012
-
European Medicines Agency. ICH topic E9: statistical principles for clinical trials (1998). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002928.pdf. Accessed January 2, 2012.
-
(1998)
ICH topic E9: Statistical principles for clinical trials
-
-
-
44
-
-
47749118439
-
Endpoints for assessing drug activity in clinical trials
-
Pazdur R.Endpoints for assessing drug activity in clinical trials.Oncologist. 2008;13 (Suppl 2): 19-21.
-
(2008)
Oncologist
, vol.13
, Issue.SUPPL. 2
, pp. 19-21
-
-
Pazdur, R.1
-
45
-
-
77954629858
-
The role of the U.S. Food and Drug Administration review process: clinical trial endpoints in oncology
-
McKee AE,Farrell AT,Pazdur R,Woodcock J.The role of the U.S. Food and Drug Administration review process: clinical trial endpoints in oncology.Oncologist. 2010;15 (Suppl 1): 13-18.
-
(2010)
Oncologist
, vol.15
, Issue.SUPPL. 1
, pp. 13-18
-
-
McKee, A.E.1
Farrell, A.T.2
Pazdur, R.3
Woodcock, J.4
-
46
-
-
44949171503
-
Adaptive design methods in clinical trials: a review
-
Chow SC,Chang M.Adaptive design methods in clinical trials: a review.Orphanet J Rare Dis. 2008;3:11.
-
(2008)
Orphanet J Rare Dis
, vol.3
, pp. 11
-
-
Chow, S.C.1
Chang, M.2
-
47
-
-
46349091495
-
Adaptive clinical trials: progress and challenges
-
Coffey CS,Kairalla JA.Adaptive clinical trials: progress and challenges.Drugs R D. 2008;9 (4): 229-242.
-
(2008)
Drugs R D
, vol.9
, Issue.4
, pp. 229-242
-
-
Coffey, C.S.1
Kairalla, J.A.2
-
48
-
-
0345424863
-
-
Food and Drug Administration, Available at, Accessed January 2, 2012
-
Food and Drug Administration. Guidance for industry: adaptive clinical trials design for drugs and biologics. Available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm201790.pdf. Accessed January 2, 2012.
-
Guidance for industry: Adaptive clinical trials design for drugs and biologics
-
-
-
49
-
-
78249278911
-
From adaptive design to modern protocol design for drug development, part I: editorial and summary of Adaptive Designs Session at the Third FDA/DIA Statistics Forum
-
Wang SJ,Bretz F.From adaptive design to modern protocol design for drug development, part I: editorial and summary of Adaptive Designs Session at the Third FDA/DIA Statistics Forum.Drug Info J. 2010;44:325-331.
-
(2010)
Drug Info J
, vol.44
, pp. 325-331
-
-
Wang, S.J.1
Bretz, F.2
-
52
-
-
33747615982
-
Partnership between small biotech and big pharma
-
Wiederrecht GJ,Hill RG,Beer MS.Partnership between small biotech and big pharma.IDrugs. 2006;9 (8): 560-564.
-
(2006)
IDrugs
, vol.9
, Issue.8
, pp. 560-564
-
-
Wiederrecht, G.J.1
Hill, R.G.2
Beer, M.S.3
-
53
-
-
69149103993
-
Deal-making trends in oncology
-
Moore K,Walker J.Deal-making trends in oncology.Nat Rev Drug Discov. 2009;8 (8): 604.
-
(2009)
Nat Rev Drug Discov
, vol.8
, Issue.8
, pp. 604
-
-
Moore, K.1
Walker, J.2
|