메뉴 건너뛰기




Volumn 6, Issue 4, 2007, Pages 451-464

Signal detection methodologies to support effective safety management

Author keywords

Pharmacovigilance; Product safety; Quantitative signal detection; Risk management

Indexed keywords

ALOSETRON; ASTEMIZOLE; AZARIBINE; BENOXAPROFEN; BROMFENAC; CERIVASTATIN; CISAPRIDE; ENCAINIDE; ETRETINATE; FANOLESOMAB TC 99M; FENFLURAMINE; FLOSEQUINAN; GREPAFLOXACIN; LEVACETYLMETHADOL; MIBEFRADIL; NATALIZUMAB; NOMIFENSINE; PEMOLINE; RAPACURONIUM BROMIDE; ROFECOXIB; SUPROFEN; TEMAFLOXACIN; TERFENADINE; TIENILIC ACID; TROGLITAZONE; VALDECOXIB; ZOMEPIRAC;

EID: 34548473335     PISSN: 14740338     EISSN: None     Source Type: Journal    
DOI: 10.1517/14740338.6.4.451     Document Type: Review
Times cited : (29)

References (75)
  • 1
    • 27544454016 scopus 로고    scopus 로고
    • FOOD AND DRUG ADMINISTRATION:, US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research CBER, USA March
    • FOOD AND DRUG ADMINISTRATION: Guidance for Industry. Premarketing Risk Assessment. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER), USA March (2005).
    • (2005) Guidance for Industry. Premarketing Risk Assessment
  • 2
    • 25444452228 scopus 로고    scopus 로고
    • FOOD AND DRUG ADMINISTRATION:, US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research CBER, USA Match
    • FOOD AND DRUG ADMINISTRATION: Guidance for Industry. Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER), USA Match (2005).
    • (2005) Guidance for Industry. Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
  • 3
    • 27544485215 scopus 로고    scopus 로고
    • FOOD AND DRUG ADMINISTRATION:, US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research CBER, USA March
    • FOOD AND DRUG ADMINISTRATION: Guidance for Industry Development and Use of Risk Minimization Action Plans. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER), USA March (2005).
    • (2005) Guidance for Industry Development and Use of Risk Minimization Action Plans
  • 5
    • 39749188910 scopus 로고    scopus 로고
    • EUROPEAN MEDICINES AGENCY (EMEA): European risk-management strategy: progress to date and next steps EMEA (2005) EMEA/136253/2005.
    • EUROPEAN MEDICINES AGENCY (EMEA): European risk-management strategy: progress to date and next steps EMEA (2005) EMEA/136253/2005.
  • 7
    • 39749130503 scopus 로고    scopus 로고
    • EUROPEAN MEDICINES AGENCY (EMEA): Action plan to further progress the European risk-management strategy EMEA (2005) EMEA/115906/2005/Final.
    • EUROPEAN MEDICINES AGENCY (EMEA): Action plan to further progress the European risk-management strategy EMEA (2005) EMEA/115906/2005/Final.
  • 8
    • 16244369779 scopus 로고    scopus 로고
    • INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE: E2E: Pharmacovigilance Planning ICH Harmonised Tripartite Guideline (2004, Federal Register (2005) 70(62):16827-16828
    • INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE: E2E: Pharmacovigilance Planning ICH Harmonised Tripartite Guideline (2004). Federal Register (2005) 70(62):16827-16828.
  • 9
    • 39749143434 scopus 로고    scopus 로고
    • Management of Safety Information
    • CIOMS WORKING GROUP VI:, Council for International Organizations of Medical Sciences, Geneva, Switzerland
    • CIOMS WORKING GROUP VI: Management of Safety Information. In: Clinical Trials. Council for International Organizations of Medical Sciences, Geneva, Switzerland (2005).
    • (2005) Clinical Trials
  • 10
    • 1242329171 scopus 로고    scopus 로고
    • Application of data mining techniques in pharmacovigilance
    • WILSON AM, THABANE L, HOLBROOK A: Application of data mining techniques in pharmacovigilance Br. J. Clin. Pharmacol. (2004) 57(2):127-134.
    • (2004) Br. J. Clin. Pharmacol , vol.57 , Issue.2 , pp. 127-134
    • WILSON, A.M.1    THABANE, L.2    HOLBROOK, A.3
  • 11
    • 26944491481 scopus 로고    scopus 로고
    • Perspectives on the use of data mining in pharmacovigilance
    • ALMENOFF J, TONNING JM, GOULD AL et al.: Perspectives on the use of data mining 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
  • 13
    • 4644278486 scopus 로고    scopus 로고
    • The role of scientific evidence of risks and benefits in determining risk management policies for medications
    • ANDREWS E, DOMBECK M: The role of scientific evidence of risks and benefits in determining risk management policies for medications. Pharmacoepidemiol. Drug Saf. (2004) 13(9):599-608.
    • (2004) Pharmacoepidemiol. Drug Saf , vol.13 , Issue.9 , pp. 599-608
    • ANDREWS, E.1    DOMBECK, M.2
  • 14
    • 0034090289 scopus 로고    scopus 로고
    • Identifying drug safety issues: From research to practice
    • GANDHI TK, SEGER DL, BATES DW: Identifying drug safety issues: from research to practice. Int. J. Qual Healthcare (2000) 12(1):69-76.
    • (2000) Int. J. Qual Healthcare , vol.12 , Issue.1 , pp. 69-76
    • GANDHI, T.K.1    SEGER, D.L.2    BATES, D.W.3
  • 15
    • 0141484568 scopus 로고    scopus 로고
    • Detecting adverse events for patient safety research: A review of current methodologies
    • MURFF HJ, PATEL VE, HRIPCSAK G, BATES DW: Detecting adverse events for patient safety research: a review of current methodologies. J. Biomed. Informatics (2003) 36:131-143.
    • (2003) J. Biomed. Informatics , vol.36 , pp. 131-143
    • MURFF, H.J.1    PATEL, V.E.2    HRIPCSAK, G.3    BATES, D.W.4
  • 17
    • 0032508249 scopus 로고    scopus 로고
    • MARTIN RM, KAPOOR KV, WILTON LV, MANN RD: Underreporting of suspected adverse drug reactions to newly marketed (black triangle drugs in general practice: observational study. BMJ (1998) 317(7151):119-120.
    • MARTIN RM, KAPOOR KV, WILTON LV, MANN RD: Underreporting of suspected adverse drug reactions to newly marketed ("black triangle" drugs in general practice: observational study. BMJ (1998) 317(7151):119-120.
  • 18
    • 0037199381 scopus 로고    scopus 로고
    • VAN DER HEIJDEN VAN PUIJENBROEK EP, VAN BUUREN S, VAN DER HOFSTEDE JW: On the assessment of adverse drug reactions from spontaneous reporting systems: the influence of under-reporting on odds ratios. Statistics Med. (2002) 21(14):2027-2044.
    • VAN DER HEIJDEN PG, VAN PUIJENBROEK EP, VAN BUUREN S, VAN DER HOFSTEDE JW: On the assessment of adverse drug reactions from spontaneous reporting systems: the influence of under-reporting on odds ratios. Statistics Med. (2002) 21(14):2027-2044.
  • 19
    • 0034749428 scopus 로고    scopus 로고
    • Some US Food and Drug Administration Perspectives on Data Mining for Pediatric Safety Assessment
    • O'NEILL R, SZARFMAN A: Some US Food and Drug Administration Perspectives on Data Mining for Pediatric Safety Assessment. Curr. Therap. Res. (2001) 62(9):650-663.
    • (2001) Curr. Therap. Res , vol.62 , Issue.9 , pp. 650-663
    • O'NEILL, R.1    SZARFMAN, A.2
  • 20
    • 39749101796 scopus 로고
    • Programmed Analysis of a 2 × 2 Contingency Table
    • MANTEL N, HANKEY BF: Programmed Analysis of a 2 × 2 Contingency Table. The American Statistician (1971) 25(5):40-44.
    • (1971) The American Statistician , vol.25 , Issue.5 , pp. 40-44
    • MANTEL, N.1    HANKEY, B.F.2
  • 22
    • 0032544993 scopus 로고    scopus 로고
    • What's the relative risk? A method of correcting the odds ratio in cohort studies of common outcomes
    • ZHANG J, YU KF: What's the relative risk? A method of correcting the odds ratio in cohort studies of common outcomes. JAMA (1998) 280(19):1690-1691.
    • (1998) JAMA , vol.280 , Issue.19 , pp. 1690-1691
    • ZHANG, J.1    YU, K.F.2
  • 23
    • 0037541565 scopus 로고    scopus 로고
    • Estimating the relative risk in cohort studies and clinical trials of common outcomes
    • MCNUTT LA, WU C, XUE X, HAFNER JP: Estimating the relative risk in cohort studies and clinical trials of common outcomes. Am. J. Epidemiol. (2003) 157(10):940-943.
    • (2003) Am. J. Epidemiol , vol.157 , Issue.10 , pp. 940-943
    • MCNUTT, L.A.1    WU, C.2    XUE, X.3    HAFNER, J.P.4
  • 24
    • 0000893164 scopus 로고
    • Fisher's Exact Test
    • UPTON G: Fisher's Exact Test. J. Royal Statist. Soc. A (1992) 155(3):395-402.
    • (1992) J. Royal Statist. Soc. A , vol.155 , Issue.3 , pp. 395-402
    • UPTON, G.1
  • 25
    • 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. The American Statistician (1999) 53(3):177-202.
    • (1999) The American Statistician , vol.53 , Issue.3 , pp. 177-202
    • DUMOUCHEL, W.1
  • 26
    • 0035700740 scopus 로고    scopus 로고
    • Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports
    • EVANS SJW, WALLER PC, DAVIS S: Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol. Drug Saf. (2001) 10:483-486.
    • (2001) Pharmacoepidemiol. Drug Saf , vol.10 , pp. 483-486
    • EVANS, S.J.W.1    WALLER, P.C.2    DAVIS, S.3
  • 27
    • 0037256026 scopus 로고    scopus 로고
    • Application of quantitative signal detection in the Dutch spontaneous reporting system for adverse drug reactions
    • VAN PUIJENBROEK EP, DIEMONT WL, VAN GROOTHEEST K: Application of quantitative signal detection in the Dutch spontaneous reporting system for adverse drug reactions. Drug Saf. (2003) 26(5):293-301.
    • (2003) Drug Saf , vol.26 , Issue.5 , pp. 293-301
    • VAN PUIJENBROEK, E.P.1    DIEMONT, W.L.2    VAN GROOTHEEST, K.3
  • 28
    • 0036210975 scopus 로고    scopus 로고
    • A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions
    • VAN PUIJENBROEK EP, BATE A, LEUFKENS HGM, LINDQUIST M, ORRE R, EGBERTS ACG: A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol. Drug Saf. (2002) 11:3-10.
    • (2002) Pharmacoepidemiol. Drug Saf , vol.11 , pp. 3-10
    • VAN PUIJENBROEK EP, B.A.1    LEUFKENS, H.G.M.2    LINDQUIST, M.3    ORRE, R.4    EGBERTS, A.C.G.5
  • 29
    • 0036303879 scopus 로고    scopus 로고
    • Use of measures of disproportionality in pharmacovigilance - three Dutch examples
    • EGBERTS ACG, MEYBOOM RHB, VAN PUIJENBROEK EP: Use of measures of disproportionality in pharmacovigilance - three Dutch examples. Drug Saf. (2002) 25(6):453-458.
    • (2002) Drug Saf , vol.25 , Issue.6 , pp. 453-458
    • EGBERTS, A.C.G.1    MEYBOOM, R.H.B.2    VAN PUIJENBROEK, E.P.3
  • 30
    • 4544368008 scopus 로고    scopus 로고
    • The reporting odds ratio and its advantages over the proportional reporting ratio
    • ROTHMAN K, LANES S, SACKS ST: The reporting odds ratio and its advantages over the proportional reporting ratio. Pharmacoepidemiol. Drug Saf. (2004) 13:519-523.
    • (2004) Pharmacoepidemiol. Drug Saf , vol.13 , pp. 519-523
    • ROTHMAN, K.1    LANES, S.2    SACKS, S.T.3
  • 32
    • 22544441973 scopus 로고    scopus 로고
    • Bayesian inference for categorical data analysis: A survey
    • Technical Report. Department of Statistics, University of Florida, USA
    • AGRESTI A, HITCHCOCK D: Bayesian inference for categorical data analysis: a survey. Technical Report. Department of Statistics, University of Florida, USA (2004).
    • (2004)
    • AGRESTI, A.1    HITCHCOCK, D.2
  • 35
    • 0031871338 scopus 로고    scopus 로고
    • A Bayesian neural network method for adverse drug reaction signal generation
    • BATE A, LINDQUIST M, EDWARDS IR et al.: A Bayesian neural network method for adverse drug reaction signal generation. Eur. J. Clin. Pharmacol. (1998) 54:315-321.
    • (1998) Eur. J. Clin. Pharmacol , vol.54 , pp. 315-321
    • BATE, A.1    LINDQUIST, M.2    EDWARDS, I.R.3
  • 36
    • 0036032338 scopus 로고    scopus 로고
    • Data-mining analyses of pharmacovigilance signals in relation to relevant comparison drugs
    • BATE A, LINDQUIST M, ORRE R, EDWARDS IR, MEYBOOM RHB: Data-mining analyses of pharmacovigilance signals in relation to relevant comparison drugs. Eur. J. Clin. Pharmacol. (2002) 58:483-490.
    • (2002) Eur. J. Clin. Pharmacol , vol.58 , pp. 483-490
    • BATE, A.1    LINDQUIST, M.2    ORRE, R.3    EDWARDS, I.R.4    MEYBOOM, R.H.B.5
  • 37
    • 77952382692 scopus 로고    scopus 로고
    • Empirical Bayesian data mining for discovering patterns in post-marketing drug safety
    • FRAM D, ALMENOFF JS, DUMOUCHEL W: Empirical Bayesian data mining for discovering patterns in post-marketing drug safety. Proceedings ACM SIGKDD (2003):359-368.
    • (2003) Proceedings ACM SIGKDD , pp. 359-368
    • FRAM, D.1    ALMENOFF, J.S.2    DUMOUCHEL, W.3
  • 38
    • 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 SG, 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.G.2    O'NEILL, R.3
  • 39
    • 39749175745 scopus 로고    scopus 로고
    • FDA increasing use of data mining to detect early safety signals
    • FOOD AND DRUG ADMINISTRATION
    • FOOD AND DRUG ADMINISTRATION: FDA increasing use of data mining to detect early safety signals. "The Pink Sheet " (2005) 67(48):9.
    • (2005) The Pink Sheet , vol.67 , Issue.48 , pp. 9
  • 40
    • 0001745298 scopus 로고
    • The interpretation of interaction in contingency tables
    • SIMPSON EH: The interpretation of interaction in contingency tables. J. Royal Statist. Soc. B (1951) 13(2):238-241.
    • (1951) J. Royal Statist. Soc. B , vol.13 , Issue.2 , pp. 238-241
    • SIMPSON, E.H.1
  • 41
    • 33645630472 scopus 로고    scopus 로고
    • HARVEY JT, TURVILLE C, BARTY SM: Data mining of the Australian adverse drug reactions database: a comparison of Bayesian and other statistical indicators. Intl. Trans. Op. Res. (2004) 11:419-433.
    • HARVEY JT, TURVILLE C, BARTY SM: Data mining of the Australian adverse drug reactions database: a comparison of Bayesian and other statistical indicators. Intl. Trans. Op. Res. (2004) 11:419-433.
  • 42
    • 84959801619 scopus 로고
    • Statistical aspects of the analysis of data from retrospective studies of disease
    • MANTEL N, HAENSZEL W: Statistical aspects of the analysis of data from retrospective studies of disease. J. Natl. Cancer Inst. (1959) 22:719-748.
    • (1959) J. Natl. Cancer Inst , vol.22 , pp. 719-748
    • MANTEL, N.1    HAENSZEL, W.2
  • 43
    • 0141729306 scopus 로고    scopus 로고
    • Practical pharmacovigilance analysis strategies
    • GOULD AL: Practical pharmacovigilance analysis strategies. Pharmacoepidemiol. Drug Saf. (2003) 12:559-574.
    • (2003) Pharmacoepidemiol. Drug Saf , vol.12 , pp. 559-574
    • GOULD, A.L.1
  • 45
    • 0034469565 scopus 로고    scopus 로고
    • Detecting drug-drug interactions using a database for spontaneous adverse drug reactions: An example with diuretics and non-steroidal anti-inflammatory drugs
    • VAN PUIJENBROEK EP, EGBERTS ACG, HEERDINK ER, LEUFKENS HGM: Detecting drug-drug interactions using a database for spontaneous adverse drug reactions: an example with diuretics and non-steroidal anti-inflammatory drugs. Eur. J. Clin. Pharmacol. (2000) 56:733-738.
    • (2000) Eur. J. Clin. Pharmacol , vol.56 , pp. 733-738
    • VAN PUIJENBROEK, E.P.1    EGBERTS, A.C.G.2    HEERDINK, E.R.3    LEUFKENS, H.G.M.4
  • 46
    • 0042413852 scopus 로고    scopus 로고
    • Disproportionality analysis using empirical Bayes data mining: A tool for the evaluation of drug interactions in the post-marketing setting
    • ALMENOFF JS, DUMOUCHEL W, KINDMAN LA, YANG X, FRAM D: Disproportionality analysis using empirical Bayes data mining: a tool for the evaluation of drug interactions in the post-marketing setting. Pharmacoepidemiol. Drug Saf. (2003) 12:517-521.
    • (2003) Pharmacoepidemiol. Drug Saf , vol.12 , pp. 517-521
    • ALMENOFF, J.S.1    DUMOUCHEL, W.2    KINDMAN, L.A.3    YANG, X.4    FRAM, D.5
  • 47
    • 39749131143 scopus 로고    scopus 로고
    • DUMOUCHEL W: New Approaches to Analysis of Spontaneous ADR Databases. In: Proceedings of the Barnett Conference on Signaling Methods and Program Design. Barnett International's Educational Services, VA, USA (2004).
    • DUMOUCHEL W: New Approaches to Analysis of Spontaneous ADR Databases. In: Proceedings of the Barnett Conference on Signaling Methods and Program Design. Barnett International's Educational Services, VA, USA (2004).
  • 48
    • 26944491340 scopus 로고    scopus 로고
    • Syndromic surveillance and risk management using Multi-item Gamma Poisson Shrinker
    • i133
    • SZARFMAN A: Syndromic surveillance and risk management using Multi-item Gamma Poisson Shrinker. J. Urban Health (2003) 80(1)(Suppl.):i133.
    • (2003) J. Urban Health , vol.80 , Issue.1 SUPPL.
    • SZARFMAN, A.1
  • 50
    • 39749139637 scopus 로고    scopus 로고
    • Drowning in information but thirsting for knowledge
    • OGENSTAD S, HATZIS C: Drowning in information but thirsting for knowledge. Appl. Clin. Trials (2000) 9(10):46-50.
    • (2000) Appl. Clin. Trials , vol.9 , Issue.10 , pp. 46-50
    • OGENSTAD, S.1    HATZIS, C.2
  • 52
    • 4444353671 scopus 로고    scopus 로고
    • Trimethoprim-induced hyperkalaemia - lessons in data mining
    • HAUBEN M: Trimethoprim-induced hyperkalaemia - lessons in data mining. Br. J. Clin. Pharm. (2004) 58(3):338-339.
    • (2004) Br. J. Clin. Pharm , vol.58 , Issue.3 , pp. 338-339
    • HAUBEN, M.1
  • 53
    • 2942735297 scopus 로고    scopus 로고
    • Comparison of data mining methodologies using Japanese spontaneous reports
    • KUBOTA K, KOIDE D, HIRAI T: Comparison of data mining methodologies using Japanese spontaneous reports. Pharmacoepidemiol. Drug Saf. (2004) 13:387-394.
    • (2004) Pharmacoepidemiol. Drug Saf , vol.13 , pp. 387-394
    • KUBOTA, K.1    KOIDE, D.2    HIRAI, T.3
  • 54
    • 16844368417 scopus 로고    scopus 로고
    • Potential utility of data-mining algorithms for early detection of potentially fatal/disabling adverse drug reactions: A retrospective evaluation
    • 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) 45:378-384.
    • (2005) J. Clin. Pharmacol , vol.45 , pp. 378-384
    • HAUBEN, M.1    REICH, L.2
  • 55
    • 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, FRAM D, DUMOUCHEL W: 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    FRAM, D.4    DUMOUCHEL, W.5
  • 56
    • 13844272269 scopus 로고    scopus 로고
    • Using simulation to assess the sensitivity and specificity of a signal detection tool for multidimensional public health surveillance data
    • ROLKA H, BRACY D, RUSSELL C, FRAM D, BALL R: Using simulation to assess the sensitivity and specificity of a signal detection tool for multidimensional public health surveillance data. Statist. Med. (2005) 24:551-562.
    • (2005) Statist. Med , vol.24 , pp. 551-562
    • ROLKA, H.1    BRACY, D.2    RUSSELL, C.3    FRAM, D.4    BALL, R.5
  • 59
    • 13844277731 scopus 로고    scopus 로고
    • Storks Deliver Babies (p = 0.008)
    • MATTHEWS R: Storks Deliver Babies (p = 0.008). Teaching Statistics (2000) 22(2):36-38.
    • (2000) Teaching Statistics , vol.22 , Issue.2 , pp. 36-38
    • MATTHEWS, R.1
  • 60
    • 4344689546 scopus 로고    scopus 로고
    • Association of asthma therapy and Churg-Strauss syndrome: An analysis of postmarketing surveillance data
    • DUMOUCHEL W, SMITH ET, 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.T.2    BEASLEY, R.3
  • 61
    • 33747845241 scopus 로고    scopus 로고
    • Contrast media and nephropathy findings from systematic analysis and food and drug administration reports of adverse effects
    • SOLOMON R, DUMOUCHEL W: Contrast media and nephropathy findings from systematic analysis and food and drug administration reports of adverse effects Invest. Radiol. (2006) 41(8):651-660.
    • (2006) Invest. Radiol , vol.41 , Issue.8 , pp. 651-660
    • SOLOMON, R.1    DUMOUCHEL, W.2
  • 64
    • 59949105831 scopus 로고    scopus 로고
    • FOOD AND DRUG ADMINISTRATION:, US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER, USA
    • FOOD AND DRUG ADMINISTRATION: CDER Report to the Nation. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), USA (2005).
    • (2005) CDER Report to the Nation
  • 65
    • 39749096116 scopus 로고    scopus 로고
    • FOOD AND DRUG ADMINISTRATION:, US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Office of Epidemiology and Biostatistics Division of Pharmacovigilance and Epidemiology Surveillance and Data Processing Branch, USA October
    • FOOD AND DRUG ADMINISTRATION: Annual Adverse Drug Experience Report 1996. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Office of Epidemiology and Biostatistics Division of Pharmacovigilance and Epidemiology Surveillance and Data Processing Branch, USA October (1997).
    • (1997) Annual Adverse Drug Experience Report 1996
  • 66
    • 0021262726 scopus 로고
    • Discovery of new adverse drug reactions. A review of the Food and Drug Administration's spontaneous reporting system
    • ROSSI AE, KNAPP DE: Discovery of new adverse drug reactions. A review of the Food and Drug Administration's spontaneous reporting system. JAMA (1984) 252(8):1030-1033.
    • (1984) JAMA , vol.252 , Issue.8 , pp. 1030-1033
    • ROSSI, A.E.1    KNAPP, D.E.2
  • 67
    • 0034748578 scopus 로고    scopus 로고
    • How the US Food and Drug Administration Defines and Detects Adverse Events
    • TRONTELL AE: How the US Food and Drug Administration Defines and Detects Adverse Events. Curr. Therap. Res. (2001) 62(9):641-649.
    • (2001) Curr. Therap. Res , vol.62 , Issue.9 , pp. 641-649
    • TRONTELL, A.E.1
  • 69
    • 39749095156 scopus 로고    scopus 로고
    • 52(SS-1):1-24
    • 52(SS-1):1-24.
  • 70
    • 39749169850 scopus 로고    scopus 로고
    • FOOD AND DRUG ADMINISTRATION: Medical Device Reporting. Code of Federal Regulations 2006, Title 21 Part 803
    • FOOD AND DRUG ADMINISTRATION: Medical Device Reporting. Code of Federal Regulations (2006), Title 21 Part 803.
  • 71
    • 0042215618 scopus 로고    scopus 로고
    • The WHO Programme for International Drug Monitoring: The Present and Future
    • Mitchard M Ed, CRC Press, Boca Raton, FL, USA
    • LINDQUIST M: The WHO Programme for International Drug Monitoring: The Present and Future. In: Electronic Communication Technologies: A Practical Guide for Healthcare Manufacturers. Mitchard M (Ed.), CRC Press, Boca Raton, FL, USA (1998):527-549.
    • (1998) Electronic Communication Technologies: A Practical Guide for Healthcare Manufacturers , pp. 527-549
    • LINDQUIST, M.1
  • 72
    • 0043217871 scopus 로고    scopus 로고
    • EDWARDS IR, OLSSON S: The WHO International Drug Monitoring Programme. In: Side Effects of Drugs, Annual 25. Aronson JK (Ed.), Elsevier Science BV, Amsterdam (2002):589-598.
    • EDWARDS IR, OLSSON S: The WHO International Drug Monitoring Programme. In: Side Effects of Drugs, Annual 25. Aronson JK (Ed.), Elsevier Science BV, Amsterdam (2002):589-598.
  • 73
    • 0003177157 scopus 로고    scopus 로고
    • Directive 2001/20/EC of the European Parliament and of the Council
    • EUROPEAN COMMISSION
    • EUROPEAN COMMISSION: Directive 2001/20/EC of the European Parliament and of the Council. Official Journal of the European Communities (2001) L121:34-44
    • (2001) Official Journal of the European Communities , vol.L121 , pp. 34-44
  • 74
    • 39749170647 scopus 로고    scopus 로고
    • REGULATORY FRAMEWORK AND MARKET AUTHORISATIONS: Pharmacovigilance - Medicinal Products for Human use and Veterinary Medicinal Products
    • EUROPEAN COMMISSION, DIRECTORATE ENTERPRISE
    • EUROPEAN COMMISSION, DIRECTORATE ENTERPRISE, REGULATORY FRAMEWORK AND MARKET AUTHORISATIONS: Pharmacovigilance - Medicinal Products for Human use and Veterinary Medicinal Products. Rules Governing Medicinal Products in the European Union (2004) 9A.
    • (2004) Rules Governing Medicinal Products in the European Union , vol.9 A


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.