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Volumn 38, Issue 4, 2015, Pages 373-382

Using VigiBase to Identify Substandard Medicines: Detection Capacity and Key Prerequisites

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

EID: 84939999184     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.1007/s40264-015-0271-2     Document Type: Article
Times cited : (20)

References (11)
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    • Blossom DB, Kallen AJ, Patel PR, et al. Outbreak of adverse reactions associated with contaminated heparin. N Engl J Med. 2008;359(25):2674–84.
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    • Blossom, D.B.1    Kallen, A.J.2    Patel, P.R.3
  • 2
    • 44849115945 scopus 로고    scopus 로고
    • Contaminated heparin associated with adverse clinical events and activation of the contact system
    • COI: 1:CAS:528:DC%2BD1cXmvFKmtb4%3D, PID: 18434646
    • Kishimoto TK, Viswanathan K, Ganguly T, et al. Contaminated heparin associated with adverse clinical events and activation of the contact system. N Engl J Med. 2008;358(23):2457–67.
    • (2008) N Engl J Med. , vol.358 , Issue.23 , pp. 2457-2467
    • Kishimoto, T.K.1    Viswanathan, K.2    Ganguly, T.3
  • 3
    • 84939972182 scopus 로고    scopus 로고
    • US Food and Drug Administration. Information on heparin. 2012. Accessed 16 Sept 2014.
    • US Food and Drug Administration. Information on heparin. 2012. http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm112597.htm. Accessed 16 Sept 2014.
  • 4
    • 84940000950 scopus 로고    scopus 로고
    • European Medicines Agency. Questions and answers on heparins. 2008. Accessed 16 Sept 2014.
    • European Medicines Agency. Questions and answers on heparins. 2008. http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2009/11/WC500015169.pdf. Accessed 16 Sept 2014.
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    • Shrinkage observed-to-expected ratios for robust and transperent large-scale pattern discovery
    • PID: 21705438
    • Norén GN, Hopstadius J, Bate A. Shrinkage observed-to-expected ratios for robust and transperent large-scale pattern discovery. Stat Methods Med Res. 2013;22(1):57–69.
    • (2013) Stat Methods Med Res. , vol.22 , Issue.1 , pp. 57-69
    • Norén, G.N.1    Hopstadius, J.2    Bate, A.3
  • 7
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    • Medicines and Healthcare Products Regulatory Agency. Levothyroxine tablet products: a review of clinical and quality considerations. 2013. Accessed 11 Feb 2015.
    • Medicines and Healthcare Products Regulatory Agency. Levothyroxine tablet products: a review of clinical and quality considerations. 2013. https://www.gov.uk/drug-device-alerts/drug-alert-levothyroxine-100mcg-tablets-recall-of-teva-uk-and-numark-branded-product. Accessed 11 Feb 2015.
  • 9
    • 84939969514 scopus 로고    scopus 로고
    • US Food and Drug Administration. FDA statement on the ranbaxy atorvastatin recall. 2012. Accessed 5 Feb 2015.
    • US Food and Drug Administration. FDA statement on the ranbaxy atorvastatin recall. 2012. http://www.fda.gov/Drugs/DrugSafety/ucm329951.htm. Accessed 5 Feb 2015.
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    • Automated method for detecting increases in frequency of spontaneous adverse event reports over time
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    • DuMouchel W, Yuen N, Payvandi N, Booth W, Rut A, Fram D. Automated method for detecting increases in frequency of spontaneous adverse event reports over time. J Biopharm Stat. 2013;23(1):161–77.
    • (2013) J Biopharm Stat. , vol.23 , Issue.1 , pp. 161-177
    • DuMouchel, W.1    Yuen, N.2    Payvandi, N.3    Booth, W.4    Rut, A.5    Fram, D.6
  • 11
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    • Pharmacovigilance for a revolving world: prospects of patient-generated data on the internet
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    • Norén GN. Pharmacovigilance for a revolving world: prospects of patient-generated data on the internet. Drug Saf. 2014;37(10):761–4.
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    • Norén, G.N.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.