메뉴 건너뛰기




Volumn , Issue , 2014, Pages 1-26

Biomarkers for drug development: The time is now!

Author keywords

[No Author keywords available]

Indexed keywords


EID: 85054398914     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1201/b16749     Document Type: Chapter
Times cited : (6)

References (43)
  • 1
    • 77954315865 scopus 로고    scopus 로고
    • MicroRNAs as biomarkers in rheumatic diseases
    • Alevizos, I. and G. G. Illei 2010. MicroRNAs as biomarkers in rheumatic diseases. Nat Rev Rheumatol 6(7): 391-398.
    • (2010) Nat Rev Rheumatol , vol.6 , Issue.7 , pp. 391-398
    • Alevizos, I.1    Illei, G.G.2
  • 2
    • 21044442672 scopus 로고    scopus 로고
    • Carbonic anhydrase IX expression predicts outcome of interleukin 2 therapy for renal cancer
    • Atkins, M. et al. 2005. Carbonic anhydrase IX expression predicts outcome of interleukin 2 therapy for renal cancer. Clin Cancer Res 11(10): 3714-3721.
    • (2005) Clin Cancer Res , vol.11 , Issue.10 , pp. 3714-3721
    • Atkins, M.1
  • 3
    • 75449083555 scopus 로고    scopus 로고
    • Isotopic biomarker discovery and application in translational medicine
    • Bayele, H. K., A. Chiti et al. 2010. Isotopic biomarker discovery and application in translational medicine. Drug Discov Today 15(3-4): 127-136.
    • (2010) Drug Discov Today , vol.15 , Issue.3-4 , pp. 127-136
    • Bayele, H.K.1    Chiti, A.2
  • 4
    • 33645959506 scopus 로고    scopus 로고
    • Transcriptional profiling of peripheral blood cells in clinical pharmacogenomic studies
    • Burczynski, M. E. and A. J. Dorner 2006. Transcriptional profiling of peripheral blood cells in clinical pharmacogenomic studies. Pharmacogenomics 7(2): 187-202.
    • (2006) Pharmacogenomics , vol.7 , Issue.2 , pp. 187-202
    • Burczynski, M.E.1    Dorner, A.J.2
  • 5
    • 59349089815 scopus 로고    scopus 로고
    • A systematic approach to biomarker discovery; preamble to “the iSBTc-FDA taskforce on immunotherapy biomarkers”
    • Butterfield, L. H., M. L. Disis et al. 2008. A systematic approach to biomarker discovery; preamble to “the iSBTc-FDA taskforce on immunotherapy biomarkers”. J Transl Med 6: 81.
    • (2008) J Transl Med , vol.6 , pp. 81
    • Butterfield, L.H.1    Disis, M.L.2
  • 6
    • 27144509163 scopus 로고    scopus 로고
    • A network-based analysis of systemic inflammation in humans
    • Calvano, S. E., W. Xiao et al. 2005. A network-based analysis of systemic inflammation in humans. Nature 4377061: 1032-1037.
    • (2005) Nature , pp. 1032-1037
    • Calvano, S.E.1    Xiao, W.2
  • 7
    • 20444505232 scopus 로고    scopus 로고
    • An array of possibilities for the study of autoimmunity
    • Fathman, C. G., L. Soares et al. 2005. An array of possibilities for the study of autoimmunity. Nature 435(7042): 605-611.
    • (2005) Nature , vol.435 , Issue.7042 , pp. 605-611
    • Fathman, C.G.1    Soares, L.2
  • 8
    • 33749319703 scopus 로고    scopus 로고
    • Type, density, and location of immune cells within human colorectal tumors predict clinical outcome
    • Galon, J. et al. 2006.Type, density, and location of immune cells within human colorectal tumors predict clinical outcome. Science, 313(5795): 1960-1964.
    • (2006) Science , vol.313 , Issue.5795 , pp. 1960-1964
    • Galon, J.1
  • 9
    • 0004128081 scopus 로고
    • The output of the heart
    • Fishman, A. P. and D. W. Richards (eds), Bethesda, MD
    • Hamilton, W. F. and D. W. Richards, 1982. The output of the heart. In: Fishman, A. P. and D. W. Richards (eds). American Physiological Society, Bethesda, MD, 83-85.
    • (1982) American Physiological Society , pp. 83-85
    • Hamilton, W.F.1    Richards, D.W.2
  • 10
    • 0036833743 scopus 로고    scopus 로고
    • The elephant in uremia: Oxidant stress as a unifying concept of cardiovascular disease in uremia
    • Himmelfarb, J., P. Stenvinkel et al. 2002. The elephant in uremia: Oxidant stress as a unifying concept of cardiovascular disease in uremia. Kidney Int 62(5): 1524-1538.
    • (2002) Kidney Int , vol.62 , Issue.5 , pp. 1524-1538
    • Himmelfarb, J.1    Stenvinkel, P.2
  • 11
    • 59849090467 scopus 로고    scopus 로고
    • Quantifying the usefulness of PD biomarkers in Phase 2 screening trials of oncology drugs
    • Holmgren, E. 2008. Quantifying the usefulness of PD biomarkers in Phase 2 screening trials of oncology drugs. Stat Med 27(24): 4928-4938.
    • (2008) Stat Med , vol.27 , Issue.24 , pp. 4928-4938
    • Holmgren, E.1
  • 12
    • 0032189130 scopus 로고    scopus 로고
    • CD4 cell count as a surrogate endpoint in HIV clinical trials: A meta-analysis of studies of the AIDS Clinical Trials Group
    • Hughes, M.D. et al. 1998. CD4 cell count as a surrogate endpoint in HIV clinical trials: A meta-analysis of studies of the AIDS Clinical Trials Group. AIDS 12(14): 1823-1832.
    • (1998) AIDS , vol.12 , Issue.14 , pp. 1823-1832
    • Hughes, M.D.1
  • 13
    • 85053327988 scopus 로고
    • Intratracheal anaesthesia: A. By nitrous oxide and oxygen. B. By nitrous oxide and oxygen under conditions of differential pressure
    • Janeway, H. H. 1913. Intratracheal anaesthesia: A. By nitrous oxide and oxygen. B. By nitrous oxide and oxygen under conditions of differential pressure. Ann Surg 58(6 Suppl): 927-933.
    • (1913) Ann Surg , vol.58 , Issue.6 , pp. 927-933
    • Janeway, H.H.1
  • 14
    • 85054654769 scopus 로고
    • Fishman, A. P., Richards D. W. (eds), American Physiological Society, Bethesda, MD
    • Katz, L. N. and H. K. Hellerstein 1982. Electrocardiography. In: Fishman, A. P., Richards D. W. (eds). American Physiological Society, Bethesda, MD, 83-85.
    • (1982) Electrocardiography , pp. 83-85
    • Katz, L.N.1    Hellerstein, H.K.2
  • 15
    • 77956430960 scopus 로고    scopus 로고
    • Clinical microfluidics for neutrophil genomics and proteomics
    • Kotz, K. T., W. Xiao et al. 2010. Clinical microfluidics for neutrophil genomics and proteomics. Nat Med 16(9): 1042-1047.
    • (2010) Nat Med , vol.16 , Issue.9 , pp. 1042-1047
    • Kotz, K.T.1    Xiao, W.2
  • 16
    • 33750362179 scopus 로고    scopus 로고
    • Cell-specific expression and pathway analyses reveal alterations in trauma-related human T cell and monocyte pathways
    • Laudanski, K., C. Miller-Graziano et al. 2006. Cell-specific expression and pathway analyses reveal alterations in trauma-related human T cell and monocyte pathways. Proc Natl Acad Sci USA 103(42): 15564-15569.
    • (2006) Proc Natl Acad Sci USA , vol.103 , Issue.42 , pp. 15564-15569
    • Laudanski, K.1    Miller-Graziano, C.2
  • 17
    • 32544451155 scopus 로고    scopus 로고
    • Fit-for-purpose method development and validation for successful biomarker measurement
    • Lee, J. W., V. Devanarayan et al. 2006. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm Res 23(2): 312-328.
    • (2006) Pharm Res , vol.23 , Issue.2 , pp. 312-328
    • Lee, J.W.1    Devanarayan, V.2
  • 18
    • 0142061128 scopus 로고    scopus 로고
    • Circulating markers of inflammation and atherosclerosis
    • Lind, L. 2003. Circulating markers of inflammation and atherosclerosis. Atherosclerosis 169: 203-214.
    • (2003) Atherosclerosis , vol.169 , pp. 203-214
    • Lind, L.1
  • 19
    • 77952130327 scopus 로고    scopus 로고
    • Research at the interface of industry, academia and regulatory science
    • Mattes, W. B. et al. 2010. Research at the interface of industry, academia and regulatory science. Nat Biotechnol 28(5): 432-433.
    • (2010) Nat Biotechnol , vol.28 , Issue.5 , pp. 432-433
    • Mattes, W.B.1
  • 20
    • 0038596591 scopus 로고
    • U.S. Department of Health, Education and Welfare Publication No. (NIH) 74-593. Washington, DC: Government Printing Office
    • National High Blood Pressure Education Program, Task Force I: Report to the Hypertension Information and Education Advisory Committee. Recommendations for a national high blood pressure data base for effective antihypertensive therapy. 1973. U.S. Department of Health, Education and Welfare Publication No. (NIH) 74-593. Washington, DC: Government Printing Office.
    • (1973) Recommendations for a national high blood pressure data base for effective antihypertensive therapy
  • 21
    • 34447555782 scopus 로고    scopus 로고
    • Mining gene expression profiles: Expression signatures as cancer phenotypes
    • Nevins, J. R. and A. Potti 2007. Mining gene expression profiles: Expression signatures as cancer phenotypes. Nat Rev Genet 8(8): 601-609.
    • (2007) Nat Rev Genet , vol.8 , Issue.8 , pp. 601-609
    • Nevins, J.R.1    Potti, A.2
  • 22
    • 34250626806 scopus 로고    scopus 로고
    • Meta-analysis: Diagnostic accuracy of anti-cyclic citrullinated peptide antibody and rheumatoid factor for rheumatoid arthritis
    • Nishimura, K., D. Sugiyama et al. 2007. Meta-analysis: Diagnostic accuracy of anti-cyclic citrullinated peptide antibody and rheumatoid factor for rheumatoid arthritis. Ann Intern Med 146: 797-808.
    • (2007) Ann Intern Med , vol.146 , pp. 797-808
    • Nishimura, K.1    Sugiyama, D.2
  • 23
    • 33847646901 scopus 로고    scopus 로고
    • Sequential gene profiling of basal cell carcinomas treated with imiquimod in a placebo-controlled study defines the requirements for tissue rejection
    • Panelli, M.C. et al. 2007. Sequential gene profiling of basal cell carcinomas treated with imiquimod in a placebo-controlled study defines the requirements for tissue rejection. Genome Biol 8(1): R8.
    • (2007) Genome Biol , vol.8 , Issue.1 , pp. R8
    • Panelli, M.C.1
  • 24
    • 0037469232 scopus 로고    scopus 로고
    • Markers of inflammation and cardiovascular disease: Application to clinical and public health practice. A statement for healthcare professionals from the Centers for Disease Control and Prevention and the American Heart Association
    • Pearson, T. A., Mensah, G. A. et al. 2003. Markers of inflammation and cardiovascular disease: Application to clinical and public health practice. A statement for healthcare professionals from the Centers for Disease Control and Prevention and the American Heart Association. Circulation 107: 499-511.
    • (2003) Circulation , vol.107 , pp. 499-511
    • Pearson, T.A.1    Mensah, G.A.2
  • 25
    • 0017599380 scopus 로고
    • Report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC I)
    • Report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC I). 1977. JAMA 237: 255-261.
    • (1977) JAMA , vol.237 , pp. 255-261
  • 26
    • 0037469255 scopus 로고    scopus 로고
    • C-reactive protein, the metabolic syndrome, and risk of incident cardiovascular events: An 8-year follow-up of 14 719 initially healthy American women
    • Ridker, P. M., J. E. Buring, N. R. Cook, N. Rifai 2003. C-reactive protein, the metabolic syndrome, and risk of incident cardiovascular events: An 8-year follow-up of 14 719 initially healthy American women. Circulation 107: 391-397.
    • (2003) Circulation , vol.107 , pp. 391-397
    • Ridker, P.M.1    Buring, J.E.2    Cook, N.R.3    Rifai, N.4
  • 27
    • 0030956673 scopus 로고    scopus 로고
    • Inflammation, aspirin, and the risk of cardiovascular disease in apparently healthy men
    • Ridker, P. M., M. Cushman, M. J. Stampfer, R. R. Tracy, C. H. Hennekens 1997. Inflammation, aspirin, and the risk of cardiovascular disease in apparently healthy men. N Engl J Med 336: 973-979.
    • (1997) N Engl J Med , vol.336 , pp. 973-979
    • Ridker, P.M.1    Cushman, M.2    Stampfer, M.J.3    Tracy, R.R.4    Hennekens, C.H.5
  • 28
    • 33748286763 scopus 로고    scopus 로고
    • Biomarker discovery and validation
    • Rifai, N. and R. E. Gerszten 2006. Biomarker discovery and validation. Clin Chem 52(9): 1635-1637.
    • (2006) Clin Chem , vol.52 , Issue.9 , pp. 1635-1637
    • Rifai, N.1    Gerszten, R.E.2
  • 29
    • 33747030845 scopus 로고    scopus 로고
    • Protein biomarker discovery and validation: The long and uncertain path to clinical utility
    • Rifai, N., M. A. Gillette et al. 2006. Protein biomarker discovery and validation: The long and uncertain path to clinical utility. Nat Biotechnol 24(8): 971-983.
    • (2006) Nat Biotechnol , vol.24 , Issue.8 , pp. 971-983
    • Rifai, N.1    Gillette, M.A.2
  • 31
    • 84926072996 scopus 로고
    • English translation, Springfield, IL: Charles C. Thomas
    • English translation: Faulconer, A. Jr, Keys, T. E. (eds.) 1965. Foundations of Anesthesiology, Vol. 2. Springfield, IL: Charles C. Thomas, 1043-1075.
    • (1965) Foundations of Anesthesiology , vol.2 , pp. 1043-1075
    • Jr, F.A.1    Keys, T.E.2
  • 32
    • 66849095271 scopus 로고    scopus 로고
    • Serum vascular endothelial growth factor and fibronectin predict clinical response to high-dose interleukin-2 therapy
    • Sabatino, M. et al. 2009. Serum vascular endothelial growth factor and fibronectin predict clinical response to high-dose interleukin-2 therapy. J Clin Oncol 27(16): 2645-2652.
    • (2009) J Clin Oncol , vol.27 , Issue.16 , pp. 2645-2652
    • Sabatino, M.1
  • 33
    • 67349165090 scopus 로고    scopus 로고
    • Latest update on the Ro/SS-A autoantibody system
    • Schulte-Pelkum, J., M. Fritzler, and M. Mahler 2009. Latest update on the Ro/SS-A autoantibody system. Autoimmun Rev 8(7): 632-637.
    • (2009) Autoimmun Rev , vol.8 , Issue.7 , pp. 632-637
    • Schulte-Pelkum, J.1    Fritzler, M.2    Mahler, M.3
  • 34
    • 78449294471 scopus 로고    scopus 로고
    • The clinical utility of precision medicine: Properly assessing the value of emerging diagnostic tests
    • Shen, B. and Hwang, J. 2010. The clinical utility of precision medicine: Properly assessing the value of emerging diagnostic tests. Clinical Pharmacology & Therapeutics 88(6): 754-756.
    • (2010) Clinical Pharmacology & Therapeutics , vol.88 , Issue.6 , pp. 754-756
    • Shen, B.1    Hwang, J.2
  • 35
    • 77952133994 scopus 로고    scopus 로고
    • Towards consensus practices to qualify safety biomarkers for use in early drug development
    • Sistare, F.D. et al. 2010. Towards consensus practices to qualify safety biomarkers for use in early drug development. Nat Biotechnol 28(5): 446-454.
    • (2010) Nat Biotechnol , vol.28 , Issue.5 , pp. 446-454
    • Sistare, F.D.1
  • 36
    • 0026323485 scopus 로고
    • Historical reflections on hypertension
    • Vertes, V., L. Tobias, and S. Galvin 1991. Historical reflections on hypertension. Prim Care 18(3): 471-482.
    • (1991) Prim Care , vol.18 , Issue.3 , pp. 471-482
    • Vertes, V.1    Tobias, L.2    Galvin, S.3
  • 37
    • 0036399255 scopus 로고    scopus 로고
    • Overview of biomarkers and surrogate endpoints in drug development
    • Wagner, J. A. 2002. Overview of biomarkers and surrogate endpoints in drug development. Dis Markers 18(2): 41-46.
    • (2002) Dis Markers , vol.18 , Issue.2 , pp. 41-46
    • Wagner, J.A.1
  • 38
    • 33845974419 scopus 로고    scopus 로고
    • Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs
    • Wagner, J. A., S. A. Williams et al. 2007. Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs. Clin Pharmacol Ther 81(1): 104-107.
    • (2007) Clin Pharmacol Ther , vol.81 , Issue.1 , pp. 104-107
    • Wagner, J.A.1    Williams, S.A.2
  • 39
    • 77954351663 scopus 로고    scopus 로고
    • Biomarkers in the development of novel medicines for the treatment of cancer
    • 2010
    • Winkler, H., 2010. Biomarkers in the development of novel medicines for the treatment of cancer. Europena Pharmaceutical Review, 2010(3).
    • (2010) Europena Pharmaceutical Review , Issue.3
    • Winkler, H.1
  • 40
    • 39649084919 scopus 로고    scopus 로고
    • The FDA critical path initiative and its influence on new drug development
    • Woodcock, J. and R. Woosley 2008. The FDA critical path initiative and its influence on new drug development. Annu Rev Med 59: 1-12.
    • (2008) Annu Rev Med , vol.59 , pp. 1-12
    • Woodcock, J.1    Woosley, R.2
  • 41
    • 33845976645 scopus 로고    scopus 로고
    • Drug development and the FDA’s Critical Path Initiative
    • Woosley, R. L. and J. Cossman 2007. Drug development and the FDA’s Critical Path Initiative. Clin Pharmacol Ther 81(1): 129-133.
    • (2007) Clin Pharmacol Ther , vol.81 , Issue.1 , pp. 129-133
    • Woosley, R.L.1    Cossman, J.2
  • 42
    • 12244291903 scopus 로고    scopus 로고
    • Expression of endocrine gland-derived vascular endothelial growth factor in ovarian carcinoma
    • Zhang, L. et al. 2003. Expression of endocrine gland-derived vascular endothelial growth factor in ovarian carcinoma. Clin Cancer Res 9(1): 264-272.
    • (2003) Clin Cancer Res , vol.9 , Issue.1 , pp. 264-272
    • Zhang, L.1
  • 43
    • 49049118310 scopus 로고    scopus 로고
    • Biomarkers in drug development
    • Zwierzina, H. 2008. Biomarkers in drug development. Ann Oncol 19 (Suppl 5): v33-37.
    • (2008) Ann Oncol , vol.19 , pp. v33-v37
    • Zwierzina, H.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.