메뉴 건너뛰기




Volumn 33, Issue 2, 2010, Pages 139-146

Prospective Data Mining of Six Products in the US FDA Adverse Event Reporting System: Disposition of Events Identified and Impact on Product Safety Profiles

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

EID: 75649103611     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.2165/11319000-000000000-00000     Document Type: Article
Times cited : (17)

References (29)
  • 1
    • 24344432126 scopus 로고    scopus 로고
    • The role of datamining in pharmacovigilance
    • Sep
    • Hauben M, Madigan D, Gerrits CM, et al. The role of datamining in pharmacovigilance. Expert Opin Drug Saf 2005 Sep; 4 (5): 929-948
    • (2005) Expert Opin Drug Saf , vol.4 , Issue.5 , pp. 929-948
    • Hauben, M.1    Madigan, D.2    Gerrits, C.M.3
  • 2
    • 34447520376 scopus 로고    scopus 로고
    • Novel statistical tools for monitoring the safety of marketed drugs
    • Aug
    • Almenoff JS, Pattishall EN, Gibbs TG, et al. Novel statistical tools for monitoring the safety of marketed drugs. Clin Pharmacol Ther 2007 Aug; 82 (2): 157-166
    • (2007) Clin Pharmacol Ther , vol.82 , Issue.2 , pp. 157-166
    • Almenoff, J.S.1    Pattishall, E.N.2    Gibbs, T.G.3
  • 3
    • 33645214423 scopus 로고    scopus 로고
    • Data mining in spontaneous reports
    • Mar
    • Bate A, Edwards IR. Data mining in spontaneous reports. Basic Clin Pharmacol Toxicol 2006 Mar; 98 (3): 324-330
    • (2006) Basic Clin Pharmacol Toxicol , vol.98 , Issue.3 , pp. 324-330
    • Bate, A.1    Edwards, I.R.2
  • 4
    • 34247464176 scopus 로고    scopus 로고
    • Datamining for signals in spontaneous reporting databases: Proceed with caution
    • Stephenson WP, Hauben M. Datamining for signals in spontaneous reporting databases: proceed with caution. Pharmacoepidemiol Drug Saf 2007; 16: 359-365
    • (2007) Pharmacoepidemiol Drug Saf , vol.16 , pp. 359-365
    • Stephenson, W.P.1    Hauben, M.2
  • 5
    • 4644298909 scopus 로고    scopus 로고
    • Early postmarketing drug safety surveillance: Data mining points to consider
    • Oct
    • Hauben M. Early postmarketing drug safety surveillance: data mining points to consider. Ann Pharmacother 2004 Oct; 38 (10): 1625-1630
    • (2004) Ann Pharmacother , vol.38 , Issue.10 , pp. 1625-1630
    • Hauben, M.1
  • 6
    • 33846665203 scopus 로고    scopus 로고
    • Potential use of data-mining algorithms for the detection of 'surprise' adverse drug reactions
    • Hauben M, Horn S, Reich L. Potential use of data-mining algorithms for the detection of 'surprise' adverse drug reactions. Drug Saf 2007; 30 (2): 143-155
    • (2007) Drug Saf , vol.30 , Issue.2 , pp. 143-155
    • Hauben, M.1    Horn, S.2    Reich, L.3
  • 7
    • 29444459131 scopus 로고    scopus 로고
    • Evaluation of statistical association measures for the automatic signal generation in pharmacovigilance
    • Dec
    • Roux E, Thiessard F, Fourrier A, et al. Evaluation of statistical association measures for the automatic signal generation in pharmacovigilance. IEEE Trans Inf Technol Biomed 2005 Dec; 9 (4): 518-527
    • (2005) IEEE Trans Inf Technol Biomed , vol.9 , Issue.4 , pp. 518-527
    • Roux, E.1    Thiessard, F.2    Fourrier, A.3
  • 8
    • 34548081712 scopus 로고    scopus 로고
    • Criteria revision and performance comparison of three methods of signal detection applied to the spontaneous reporting database of a pharmaceutical manufacturer
    • Matsushita Y, Kuroda Y, Niwa S, et al. Criteria revision and performance comparison of three methods of signal detection applied to the spontaneous reporting database of a pharmaceutical manufacturer. Drug Saf 2007; 30 (8): 715-726
    • (2007) Drug Saf , vol.30 , Issue.8 , pp. 715-726
    • Matsushita, Y.1    Kuroda, Y.2    Niwa, S.3
  • 9
    • 33749440305 scopus 로고    scopus 로고
    • Comparative performance of two quantitative safety signalling methods: Implications for use in a pharmacovigilance department
    • Almenoff JS, LaCroix KK, Yuen NA, et al. Comparative performance of two quantitative safety signalling methods: implications for use in a pharmacovigilance department. Drug Saf 2006; 29 (10): 875-887
    • (2006) Drug Saf , vol.29 , Issue.10 , pp. 875-887
    • Almenoff, J.S.1    Lacroix, K.K.2    Yuen, N.A.3
  • 10
    • 2942735297 scopus 로고    scopus 로고
    • Comparison of data mining methodologies using Japanese spontaneous reports
    • Jun
    • Kubota K, Koide D, Hirai T. Comparison of data mining methodologies using Japanese spontaneous reports. Phar-macoepidemiol Drug Saf 2004 Jun; 13 (6): 387-394
    • (2004) Phar-macoepidemiol Drug Saf , vol.13 , Issue.6 , pp. 387-394
    • Kubota, K.1    Koide, D.2    Hirai, T.3
  • 11
    • 0141729306 scopus 로고    scopus 로고
    • Practical pharmacovigilance analysis strategies
    • Oct-Nov
    • Gould AL. Practical pharmacovigilance analysis strategies. Pharmacoepidemiol Drug Saf 2003 Oct-Nov; 12 (7): 559-574
    • (2003) Pharmacoepidemiol Drug Saf , vol.12 , Issue.7 , pp. 559-574
    • Gould, A.L.1
  • 12
    • 0036210975 scopus 로고    scopus 로고
    • A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions
    • Jan-Feb
    • van Puijenbroek EP, Bate A, Leufkens HG, et al. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf 2002 Jan-Feb; 11 (1): 3-10
    • (2002) Pharmacoepidemiol Drug Saf , vol.11 , Issue.1 , pp. 3-10
    • Van Puijenbroek, E.P.1    Bate, A.2    Leufkens, H.G.3
  • 13
    • 0034530769 scopus 로고    scopus 로고
    • A retrospective evaluation of a data mining approach to aid finding new adverse drug reaction signals in the WHO international database
    • Dec
    • Lindquist M, Stahl M, Bate A, et al. A retrospective evaluation of a data mining approach to aid finding new adverse drug reaction signals in the WHO international database. Drug Saf 2000 Dec; 23 (6): 533-542
    • (2000) Drug Saf , vol.23 , Issue.6 , pp. 533-542
    • Lindquist, M.1    Stahl, M.2    Bate, A.3
  • 14
    • 34447576566 scopus 로고    scopus 로고
    • An evaluation of computer-aided disproportionality analysis for post-marketing signal detection
    • Aug
    • Lehman HP, Chen J, Gould AL, et al. An evaluation of computer-aided disproportionality analysis for post-marketing signal detection. Clin Pharmacol Ther 2007 Aug; 82 (2): 173-180
    • (2007) Clin Pharmacol Ther , vol.82 , Issue.2 , pp. 173-180
    • Lehman, H.P.1    Chen, J.2    Gould, A.L.3
  • 15
    • 0035513985 scopus 로고    scopus 로고
    • Determinants of signal selection in a spontaneous reporting system for adverse drug reactions
    • Nov
    • van Puijenbroek EP, van Grootheest K, Diemont WL, et al. Determinants of signal selection in a spontaneous reporting system for adverse drug reactions. Br J Clin Pharmacol 2001 Nov; 52 (5): 579-586
    • (2001) Br J Clin Pharmacol , vol.52 , Issue.5 , pp. 579-586
    • Van Puijenbroek, E.P.1    Van Grootheest, K.2    Diemont, W.L.3
  • 16
    • 16844368417 scopus 로고    scopus 로고
    • Potential utility of data-mining algorithms for early detection of potentially fatal/disabling adverse drug reactions: A retrospective evaluation
    • Apr
    • Hauben M, Reich L. Potential utility of data-mining algorithms for early detection of potentially fatal/disabling adverse drug reactions: a retrospective evaluation. J Clin Pharmacol 2005 Apr; 45: 378-384
    • (2005) J Clin Pharmacol , vol.45 , pp. 378-384
    • Hauben, M.1    Reich, L.2
  • 17
    • 4344689546 scopus 로고    scopus 로고
    • Association of asthma therapy and churg-strauss syndrome: An analysis of postmarketing surveillance data
    • DuMouchel W, Smith E, Beasley R, et al. Association of asthma therapy and churg-strauss syndrome: an analysis of postmarketing surveillance data. Clin Ther 2004; 26 (7): 1092-1104
    • (2004) Clin Ther , vol.26 , Issue.7 , pp. 1092-1104
    • Dumouchel, W.1    Smith, E.2    Beasley, R.3
  • 18
    • 26944491481 scopus 로고    scopus 로고
    • Perspective on the use of datamining in pharmacovigilance
    • Almenoff J, Tonning JM, Gould AL, et al. Perspective on the use of datamining in pharmacovigilance. Drug Saf 2005; 28 (11): 981-1007
    • (2005) Drug Saf , vol.28 , Issue.11 , pp. 981-1007
    • Almenoff, J.1    Tonning, J.M.2    Gould, A.L.3
  • 19
    • 0035700740 scopus 로고    scopus 로고
    • Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports
    • Oct-Nov
    • Evans SJ, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf 2001 Oct-Nov; 10 (6): 483-486
    • (2001) Pharmacoepidemiol Drug Saf , vol.10 , Issue.6 , pp. 483-486
    • Evans, S.J.1    Waller, P.C.2    Davis, S.3
  • 20
    • 0031871338 scopus 로고    scopus 로고
    • A Bayesian neural network method for adverse drug reaction signal generation
    • Jun
    • Bate A, Lindquist M, Edwards IR, et al. A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol 1998 Jun; 54 (4): 315-321
    • (1998) Eur J Clin Pharmacol , vol.54 , Issue.4 , pp. 315-321
    • Bate, A.1    Lindquist, M.2    Edwards, I.R.3
  • 21
    • 33750336301 scopus 로고    scopus 로고
    • Extending the methods used to screen the WHO drug safety database towards analysis of complex associations and improved accuracy for rare events. Stat Med
    • Noren GN, Bate A, Orre R, et al. Extending the methods used to screen the WHO drug safety database towards analysis of complex associations and improved accuracy for rare events. Stat Med 2006 Nov 15; 25 (21): 3740-3757
    • (2006) Nov 15 , vol.25 , Issue.21 , pp. 3740-3757
    • Noren, G.N.1    Bate, A.2    Orre, R.3
  • 22
    • 0038931405 scopus 로고    scopus 로고
    • Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system
    • DuMouchel W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am Stat 1999; 53 (3): 177-190
    • (1999) Am Stat , vol.53 , Issue.3 , pp. 177-190
    • Dumouchel, W.1
  • 23
    • 0037765092 scopus 로고    scopus 로고
    • A brief primer on automated signal detection
    • Jul-Aug
    • Hauben M. A brief primer on automated signal detection. Ann Pharmacother 2003 Jul-Aug; 37 (7-8): 1117-1123
    • (2003) Ann Pharmacother , vol.37 , Issue.7-8 , pp. 1117-1123
    • Hauben, M.1
  • 24
    • 0037221866 scopus 로고    scopus 로고
    • Quantitative methods in pharmaco-vigilance: Focus on signal detection
    • Hauben M, Zhou X. Quantitative methods in pharmaco-vigilance: focus on signal detection. Drug Saf 2003; 26 (3): 159-186
    • (2003) Drug Saf , vol.26 , Issue.3 , pp. 159-186
    • Hauben, M.1    Zhou, X.2
  • 25
    • 0036300732 scopus 로고    scopus 로고
    • Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the us FDA's spontaneous reports database
    • Szarfman A, Machado S, O'Neill R. Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the us FDA's spontaneous reports database. Drug Saf 2002; 25 (6): 381-392
    • (2002) Drug Saf , vol.25 , Issue.6 , pp. 381-392
    • Szarfman, A.1    MacHado, S.2    O'Neill, R.3
  • 26
    • 12444344855 scopus 로고    scopus 로고
    • Postmarketing surveillance of potentially fatal reactions to oncology drugs: Potential utility of two signal-detection algorithms
    • Hauben M, Reich L, Chung S. Postmarketing surveillance of potentially fatal reactions to oncology drugs: potential utility of two signal-detection algorithms. Eur J Clin Pharmacol 2004; 60: 747-750
    • (2004) Eur J Clin Pharmacol , vol.60 , pp. 747-750
    • Hauben, M.1    Reich, L.2    Chung, S.3
  • 27
    • 34147138368 scopus 로고    scopus 로고
    • Illusions of objectivity and a recommendation for reporting data mining results
    • May
    • Hauben M, Reich L, Gerrits CM, et al. Illusions of objectivity and a recommendation for reporting data mining results. Eur J Clin Pharmacol 2007 May; 63 (5): 517-521
    • (2007) Eur J Clin Pharmacol , vol.63 , Issue.5 , pp. 517-521
    • Hauben, M.1    Reich, L.2    Gerrits, C.M.3
  • 28
    • 4344689776 scopus 로고    scopus 로고
    • Safety related drug-labelling changes: Findings from two data mining algorithms
    • Hauben M, Reich L. Safety related drug-labelling changes: findings from two data mining algorithms. Drug Saf 2004; 27 (10): 735-744
    • (2004) Drug Saf , vol.27 , Issue.10 , pp. 735-744
    • Hauben, M.1    Reich, L.2
  • 29
    • 35148890461 scopus 로고    scopus 로고
    • Using data mining to predict safety actions from FDA adverse event reporting system data
    • Hochberg AM, Reisinger SJ, Pearson RK, et al. Using data mining to predict safety actions from FDA adverse event reporting system data. Drug Info J 2007; 41 (5): 633-643
    • (2007) Drug Info J , vol.41 , Issue.5 , pp. 633-643
    • Hochberg, A.M.1    Reisinger, S.J.2    Pearson, R.K.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.