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Volumn 6, Issue 2, 2013, Pages 102-107

Analyzing Global Trends of Biomarker use in Drug Interventional Clinical Studies

Author keywords

clinical study efficiency; Drug development; industrial policy

Indexed keywords


EID: 85008748716     PISSN: 18817831     EISSN: 1881784x     Source Type: Journal    
DOI: 10.5582/ddt.2012.v6.2.102     Document Type: Article
Times cited : (12)

References (14)
  • 2
    • 0037374498 scopus 로고    scopus 로고
    • The price of innovation:New estimates of drug development costs
    • DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: New estimates of drug development costs. J Health Econ. 2003; 22: 151-185.
    • (2003) J Health Econ. , vol.22 , pp. 151-185
    • DiMasi, J.A.1    Hansen, R.W.2    Grabowski, H.G.3
  • 3
    • 85008743185 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration
    • March. http://www.fda.gov/downloads/ ScienceResearch/SpecialTopics/CriticalPathlnitiative/ CriticalPathOpportunitiesReports/UCM077258.pdf (accessed February 6, 2012)
    • US Department of Health and Human Services, Food and Drug Administration. Critical Path Opportunities List, March 2006. http://www.fda.gov/downloads/ ScienceResearch/SpecialTopics/CriticalPathlnitiative/ CriticalPathOpportunitiesReports/UCM077258.pdf (accessed February 6, 2012).
    • (2006) Critical Path Opportunities List
  • 5
    • 85008741239 scopus 로고    scopus 로고
    • Guidelines for ATC classification and DDD assignment 2011
    • WHO Collaborating Centre for Drug Statistics Methodology. Guidelines for ATC classification and DDD assignment 2011. Oslo, 2010.
    • Oslo , pp. 2010
  • 6
    • 77149155968 scopus 로고    scopus 로고
    • Trends in risks associated with new drug development:Success rates for investigational drugs
    • DiMasi JA, Feldman L, Secker A, Wilson A. Trends in risks associated with new drug development: Success rates for investigational drugs. Clin Pharmacol Ther. 2010; 87:272-277.
    • (2010) Clin Pharmacol Ther. , vol.87 , pp. 272-277
    • DiMasi, J.A.1    Feldman, L.2    Secker, A.3    Wilson, A.4
  • 8
    • 85008723882 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration. Guidance for Industry, Qualification Process for Drug Development Tool
    • (accessed February 6, 2012)
    • US Department of Health and Human Services, Food and Drug Administration. Guidance for Industry, Qualification Process for Drug Development Tool, October 2010. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ UCM230597.pdf (accessed February 6, 2012).
    • (2010) http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ UCM230597.pdf
  • 9
    • 85008735813 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration.
    • Draft Guidance for Industry and FDA Staff, In Vitro Companion Diagnostic Devices, July 2011. http://www.fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ UCM262327.pdf (accessed February 6).
    • US Department of Health and Human Services, Food and Drug Administration. Draft Guidance for Industry and FDA Staff, In Vitro Companion Diagnostic Devices, July 2011. http://www.fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ UCM262327.pdf (accessed February 6, 2012).
    • (2012)
  • 10
    • 49949090275 scopus 로고    scopus 로고
    • The role of ethnicity in variability in response to drugs:Focus on clinical pharmacology studies
    • Yasuda SU, Zhang L, Huang SM. The role of ethnicity in variability in response to drugs: Focus on clinical pharmacology studies. Clin Pharmacol Ther. 2008; 84: 417-423.
    • (2008) Clin Pharmacol Ther. , vol.84 , pp. 417-423
    • Yasuda, S.U.1    Zhang, L.2    Huang, S.M.3
  • 11
    • 77952189195 scopus 로고    scopus 로고
    • Approval of new drugs 1999-2007:Comparison of the US, the EU and Japan situations
    • Tsuji K, Tsutani K. Approval of new drugs 1999-2007: Comparison of the US, the EU and Japan situations. J Clin Pharm Ther. 2010; 35:289-301.
    • (2010) J Clin Pharm Ther. , vol.35 , pp. 289-301
    • Tsuji, K.1    Tsutani, K.2
  • 12
    • 85008735813 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration.
    • FDA, EMA to Consider Additional Test Results When Assessing New Drug Safety, June 2008. http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/2008/ucm116911.htm (accessed February 6).
    • US Department of Health and Human Services, Food and Drug Administration. FDA, EMA to Consider Additional Test Results When Assessing New Drug Safety, June 2008. http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/2008/ucm116911.htm (accessed February 6, 2012).
    • (2012)
  • 13
    • 84872296540 scopus 로고    scopus 로고
    • May. http://www.pmda.go.jp/operations/shonin/ info/consult/file/pbm-kiroku-e.pdf (accessed February 6, 2012).
    • Pharmaceuticals and Medical Devices Agency. Record of the Consultation on Pharmacogenomics/Biomarkers, May 2010. http://www.pmda.go.jp/operations/shonin/ info/consult/file/pbm-kiroku-e.pdf (accessed February 6, 2012).
    • (2010) Record of the Consultation on Pharmacogenomics/Biomarkers


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.