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Volumn 9, Issue 10, 2014, Pages

Inconsistencies among European Union pharmaceutical regulator safety communications: A cross-country comparison

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; COMPARATIVE STUDY; CONTROLLED STUDY; CROSS-SECTIONAL STUDY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FRANCE; HEALTH CARE POLICY; MEDICAL INFORMATION; MEDICAL SOCIETY; NETHERLANDS; PHARMACEUTICAL CARE; POSTMARKETING SURVEILLANCE; PRESCRIPTION; PUBLIC HEALTH; SPAIN; UNITED KINGDOM; DRUG LEGISLATION; DRUG RECALL; EUROPEAN UNION; HUMAN; INTERNATIONAL COOPERATION; ORGANIZATION AND MANAGEMENT; STANDARDS;

EID: 84908190355     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0109100     Document Type: Article
Times cited : (20)

References (10)
  • 1
    • 84877937009 scopus 로고    scopus 로고
    • Advances in regulatory science at the food and drug administration
    • Psaty BM, Goodman SN, Breckenridge A (2013) Advances in regulatory science at the Food and Drug Administration. JAMA 309: 2103-2104.
    • (2013) JAMA , vol.309 , pp. 2103-2104
    • Psaty, B.M.1    Goodman, S.N.2    Breckenridge, A.3
  • 2
    • 84862487910 scopus 로고    scopus 로고
    • A lifecycle approach to the evaluation of FDA approval methods and regulatory actions: Opportunities provided by a new IOM report
    • Psaty BM, Meslin EM, Breckenridge A (2012) A lifecycle approach to the evaluation of FDA approval methods and regulatory actions: opportunities provided by a new IOM report. JAMA 307: 2491-2492.
    • (2012) JAMA , vol.307 , pp. 2491-2492
    • Psaty, B.M.1    Meslin, E.M.2    Breckenridge, A.3
  • 3
    • 53249132632 scopus 로고    scopus 로고
    • Balancing early market access to new drugs with the need for benefit/risk data: A mounting dilemma
    • Eichler HG, Pignatti F, Flamion B, Leufkens H, Breckenridge A (2008) Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma. Nat Rev Drug Discov 7: 818-826.
    • (2008) Nat Rev Drug Discov , vol.7 , pp. 818-826
    • Eichler, H.G.1    Pignatti, F.2    Flamion, B.3    Leufkens, H.4    Breckenridge, A.5
  • 6
    • 77952855654 scopus 로고    scopus 로고
    • A decade of safety-related regulatory action in the Netherlands: A retrospective analysis of direct healthcare professional communications from 1999 to 2009
    • Mol PG, Straus SM, Piening S, de Vries JT, de Graeff PA, et al. (2010) A decade of safety-related regulatory action in the Netherlands: a retrospective analysis of direct healthcare professional communications from 1999 to 2009. Drug Saf 33: 463-474.
    • (2010) Drug Saf , vol.33 , pp. 463-474
    • Mol, P.G.1    Straus, S.M.2    Piening, S.3    De Vries, J.T.4    De Graeff, P.A.5
  • 7
    • 3042723720 scopus 로고    scopus 로고
    • Adverse drug reactions as cause of admission to hospital: Prospective analysis of 18 820 patients
    • Pirmohamed M, James S, Meakin S, Green C, Scott AK, et al. (2004) Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ 329: 15-19.
    • (2004) BMJ , vol.329 , pp. 15-19
    • Pirmohamed, M.1    James, S.2    Meakin, S.3    Green, C.4    Scott, A.K.5
  • 8
    • 54349091558 scopus 로고    scopus 로고
    • Safety-related regulatory actions for biologicals approved in the United States and the European union
    • Giezen TJ, Mantel-Teeuwisse AK, Straus SM, Schellekens H, Leufkens HG, et al. (2008) Safety-related regulatory actions for biologicals approved in the United States and the European Union. JAMA 300: 1887-1896.
    • (2008) JAMA , vol.300 , pp. 1887-1896
    • Giezen, T.J.1    Mantel-Teeuwisse, A.K.2    Straus, S.M.3    Schellekens, H.4    Leufkens, H.G.5
  • 9
    • 18544372466 scopus 로고    scopus 로고
    • Understanding interobserver agreement: The kappa statistic
    • Viera AJ, Garrett JM (2005) Understanding interobserver agreement: the kappa statistic. Fam Med 37: 360-363.
    • (2005) Fam Med , vol.37 , pp. 360-363
    • Viera, A.J.1    Garrett, J.M.2
  • 10
    • 84878336121 scopus 로고    scopus 로고
    • The European medicines agency's plans for sharing data from clinical trials
    • Groves T, Godlee F (2013) The European Medicines Agency's plans for sharing data from clinical trials. BMJ 346: f2961.
    • (2013) BMJ , vol.346
    • Groves, T.1    Godlee, F.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.