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Volumn 31, Issue 5, 2010, Pages 411-413

Academic perspectives on the United States food and drug administration's guidance for industry on diabetes mellitus

Author keywords

Diabetes mellitus; Food and Drug Administration

Indexed keywords

INSULIN; METFORMIN; PLACEBO; ROSIGLITAZONE; SULFONYLUREA;

EID: 77957751400     PISSN: 15517144     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cct.2010.06.001     Document Type: Article
Times cited : (11)

References (12)
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    • Guidance for Industry: Diabetes Mellitus-Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes. US DHHS, FDA, CDER, December 2008.
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  • 2
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    • Implications of overviews for randomized trials
    • Hennekens C.H., Buring J.E., Hebert P. Implications of overviews for randomized trials. Stat Med 1987, 6:397-402.
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    • Hennekens, C.H.1    Buring, J.E.2    Hebert, P.3
  • 3
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    • The need for large scale randomized evidence without undue reliance on small trials, their meta-analyses or subgroup analyses
    • Hennekens C.H., DeMets D. The need for large scale randomized evidence without undue reliance on small trials, their meta-analyses or subgroup analyses. JAMA 2009, 302:2361-2362.
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    • Hennekens, C.H.1    DeMets, D.2
  • 4
    • 77957755944 scopus 로고    scopus 로고
    • Fundamentals of Clinical Trials. John Wright-PSG Inc., Littleton, MA, 1981; 3rd edition Springer-Verlag, New York, NY.
    • L. Friedman, C. Furberg, D. Demets. Fundamentals of Clinical Trials. John Wright-PSG Inc., Littleton, MA, 1981; 3rd edition 1998 Springer-Verlag, New York, NY.
    • (1998)
    • Friedman, L.1    Furberg, C.2    Demets, D.3
  • 6
    • 34250212715 scopus 로고    scopus 로고
    • Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes
    • Nissen S., Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007, 356:2457-2471.
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    • Nissen, S.1    Wolski, K.2
  • 8
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    • For the RECORD Study Group. Rosiglitazone evaluated for cardiovascular outcomes-an interim analysis
    • Home P.D., Pocock S.J., Beck-Nielsen H., et al. For the RECORD Study Group. Rosiglitazone evaluated for cardiovascular outcomes-an interim analysis. N Engl J Med 2007, 357:28-38.
    • (2007) N Engl J Med , vol.357 , pp. 28-38
    • Home, P.D.1    Pocock, S.J.2    Beck-Nielsen, H.3
  • 9
    • 34250826679 scopus 로고    scopus 로고
    • Rosiglitazone and cardiotoxicity-weighing the evidence
    • Nathan D.M. Rosiglitazone and cardiotoxicity-weighing the evidence. N Engl J Med 2007, 357:64-66.
    • (2007) N Engl J Med , vol.357 , pp. 64-66
    • Nathan, D.M.1
  • 10
    • 34250828630 scopus 로고    scopus 로고
    • The record on rosiglitazone and the risk of myocardial infarction
    • Psaty B.M., Furberg C.D. The record on rosiglitazone and the risk of myocardial infarction. N Engl J Med 2007, 357:67-69.
    • (2007) N Engl J Med , vol.357 , pp. 67-69
    • Psaty, B.M.1    Furberg, C.D.2
  • 11
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    • For the RECORD Study Group. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial
    • Home P.D., Pocock S.J., Beck-Nielsen H., et al. For the RECORD Study Group. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet 2009, 373:2125-2135.
    • (2009) Lancet , vol.373 , pp. 2125-2135
    • Home, P.D.1    Pocock, S.J.2    Beck-Nielsen, H.3
  • 12
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    • Discrepancies between meta-analyses and subsequent large randomized, controlled trials
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* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.