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Volumn 300, Issue 8, 2008, Pages 952-954

Opportunities for enhancing the FDA guidance on pharmacovigilance

Author keywords

[No Author keywords available]

Indexed keywords

ROSIGLITAZONE;

EID: 50549098780     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.300.8.952     Document Type: Note
Times cited : (16)

References (15)
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    • Food and Drug Administration. Developing guidance on conducting scientifically sound pharmacoepidemiologic safety studies using large electronic healthcare data sets: public workshop: request for comments. Fed Regist. 2008;73(79):21963-21964.
    • (2008) Fed Regist , vol.73 , Issue.79 , pp. 21963-21964
  • 4
    • 33845405222 scopus 로고    scopus 로고
    • ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy
    • Kahn SE, Haffner SM, Heise MA, et al; ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006;355(23):2427-2443.
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    • Kahn, S.E.1    Haffner, S.M.2    Heise, M.A.3
  • 5
    • 33748748206 scopus 로고    scopus 로고
    • Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: A randomised controlled trial
    • Gerstein HC, Yusuf S, Bosch J, et al. Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled trial. Lancet. 2006;368(9541):1096-1105.
    • (2006) Lancet , vol.368 , Issue.9541 , pp. 1096-1105
    • Gerstein, H.C.1    Yusuf, S.2    Bosch, J.3
  • 6
    • 34250865768 scopus 로고    scopus 로고
    • Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) Study: Interim findings on cardiovascular hospitalizations and deaths
    • Home PD, Pocock SJ, Beck-Nielsen H, et al. Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) Study: interim findings on cardiovascular hospitalizations and deaths. N Engl J Med. 2007;357(1):28-38.
    • (2007) N Engl J Med , vol.357 , Issue.1 , pp. 28-38
    • Home, P.D.1    Pocock, S.J.2    Beck-Nielsen, H.3
  • 7
    • 34250212715 scopus 로고    scopus 로고
    • Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes
    • Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007;356(24):2457-2472.
    • (2007) N Engl J Med , vol.356 , Issue.24 , pp. 2457-2472
    • Nissen, S.E.1    Wolski, K.2
  • 8
    • 41549117102 scopus 로고    scopus 로고
    • Observational research, randomised trials, and two views of medical science
    • supplemental material
    • Vandenbroucke J. Observational research, randomised trials, and two views of medical science. PLoS Med. 2008;5:e67; supplemental material. http://medicine.plosjournals.org/archive/1549-1676/5/3/supinfo/10.1371_journal. pmed.0050067.sd001.pdf.
    • (2008) PLoS Med , vol.5
    • Vandenbroucke, J.1
  • 10
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    • FDA guidance on off-label promotion and the state of the literature from sponsors
    • Psaty BM, Ray W. FDA guidance on off-label promotion and the state of the literature from sponsors. JAMA. 2008;299(16):1949-1951.
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    • Psaty, B.M.1    Ray, W.2
  • 11
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    • Food and Drug Administration Amendments Act of, Pub L, Accessed October 11, 2007
    • Food and Drug Administration Amendments Act of 2007. HR 3580, enacted by the House and Senate, Pub L No. 110-85. http://frwebgate.access.gpo.gov/cgi-bin/ getdoc.cgi?dbname=110_cong_bills&docid=f:h3580enr.txt.pdf. Accessed October 11, 2007.
    • (2007) HR 3580, enacted by the House and Senate , Issue.110-185
  • 12
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    • STROBE Initiative: The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies
    • von Elm E, Altman D, Egger M, Pocock S, Götzsche P, Vandenbroucke J. STROBE Initiative: The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med. 2007;147(8):573-577.
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  • 14
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    • Major outcomes in moderately hypercholesterolemic, hypertensive patients randomized to pravastatin vs usual care: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT)
    • ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group
    • ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in moderately hypercholesterolemic, hypertensive patients randomized to pravastatin vs usual care: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT). JAMA. 2002;288(23):2998-3007.
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    • Gerstein, H.C.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.