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Volumn 34, Issue 6, 2008, Pages 415-416

Phase IV research: Innovation in need of ethics

Author keywords

[No Author keywords available]

Indexed keywords

AGED; EDITORIAL; ETHICS; FEMALE; HUMAN; MALE; PHASE 4 CLINICAL TRIAL; RESEARCH ETHICS; RESEARCH SUBJECT; STANDARD;

EID: 55249094155     PISSN: 03066800     EISSN: 14734257     Source Type: Journal    
DOI: 10.1136/jme.2007.023911     Document Type: Editorial
Times cited : (8)

References (13)
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    • Vlahakes GJ. The value of phase IV clinical testing. N Engl J Med 2006;354:413-15.
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  • 3
    • 56749125725 scopus 로고    scopus 로고
    • Dose optimization in drug development: Role of phase IV trials
    • Joubert PH. Dose optimization in drug development: role of phase IV trials. Int Congr Ser 2001;1220:51-65.
    • (2001) Int Congr Ser , vol.1220 , pp. 51-65
    • Joubert, P.H.1
  • 4
    • 0347946753 scopus 로고    scopus 로고
    • Differences between clinical trials and postmarketing use
    • Martin K, Bégaud B, Latry P, et al. Differences between clinical trials and postmarketing use. Br J Clin Pharmacol 2003;57:86-92.
    • (2003) Br J Clin Pharmacol , vol.57 , pp. 86-92
    • Martin, K.1    Bégaud, B.2    Latry, P.3
  • 5
    • 33846083812 scopus 로고    scopus 로고
    • Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization
    • van Luijn JCF, Gribnau FWJ, Leufkens HGM. Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization. Br J Clin Pharmacol 2007;63:159-62.
    • (2007) Br J Clin Pharmacol , vol.63 , pp. 159-162
    • van Luijn, J.C.F.1    Gribnau, F.W.J.2    Leufkens, H.G.M.3
  • 6
    • 34248213019 scopus 로고    scopus 로고
    • Report on the performance of drug and biologics firms in conducting postmarketing commitment studies; availability
    • Food and Drug Administration
    • Food and Drug Administration. Report on the performance of drug and biologics firms in conducting postmarketing commitment studies; availability. Fed Regist 2007;72:5069-70.
    • (2007) Fed Regist , vol.72 , pp. 5069-5070
  • 8
    • 33748496245 scopus 로고    scopus 로고
    • The problem with optimism in clinical trials
    • Jansen LA. The problem with optimism in clinical trials. IRB 2006;28:13-19.
    • (2006) IRB , vol.28 , pp. 13-19
    • Jansen, L.A.1
  • 9
    • 56749162294 scopus 로고    scopus 로고
    • National coverage determinations with data collection as a condition of coverage: Coverage with evidence development
    • 12 July 2006 At, accessed 14 Mar 2008
    • Centers for Medicare & Medicaid Services. National coverage determinations with data collection as a condition of coverage: coverage with evidence development. Guidance for the public, industry and CMS staff. (12 July 2006) At http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=8 (accessed 14 Mar 2008).
    • Guidance for the public, industry and CMS staff
  • 10
    • 34247192001 scopus 로고    scopus 로고
    • The FDA and the case of Ketek
    • Ross DB. The FDA and the case of Ketek. N Engl J Med 2007;356:1601-4.
    • (2007) N Engl J Med , vol.356 , pp. 1601-1604
    • Ross, D.B.1
  • 11
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    • How conducting a clinical trial affects physicians'guideline adherence and drug preferences
    • Andersen M, Kragstrup J, Sondergaard J. How conducting a clinical trial affects physicians'guideline adherence and drug preferences. JAMA 2006;295:2759-64.
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    • Andersen, M.1    Kragstrup, J.2    Sondergaard, J.3
  • 12
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    • What makes clinical research ethical?
    • Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701-11.
    • (2000) JAMA , vol.283 , pp. 2701-2711
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  • 13
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    • Research 2001-2002. Geneva: GFHR xv
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* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.