-
1
-
-
60749099873
-
Defining 'Signal' and its subtypes in pharmacovigilance based on a systematic review of previous definitions
-
Hauben M., Aronson JK. Defining 'Signal' and its subtypes in pharmacovigilance based on a systematic review of previous definitions. Drug Saf 2009; 32(2): 99-110.
-
(2009)
Drug Saf
, vol.32
, Issue.2
, pp. 99-110
-
-
Hauben, M.1
Aronson, J.K.2
-
2
-
-
0141729306
-
Practical pharmacovigilance analysis strategies
-
Gould AL. Practical pharmacovigilance analysis strategies. Pharmacoepidemiol Drug Saf 2003; 12(7): 559-574.
-
(2003)
Pharmacoepidemiol Drug Saf
, vol.12
, Issue.7
, pp. 559-574
-
-
Gould, A.L.1
-
3
-
-
68149124572
-
Quantitative signal detection using spontaneous ADR reporting
-
Bate A, Evans SJW. Quantitative signal detection using spontaneous ADR reporting. Pharmacoepidemiol Drug Saf 2009; 18(6): 427-436.
-
(2009)
Pharmacoepidemiol Drug Saf
, vol.18
, Issue.6
, pp. 427-436
-
-
Bate, A.1
Evans, S.J.W.2
-
4
-
-
0035700740
-
Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports
-
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; 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
-
5
-
-
0042073442
-
Statistical methods of signal detection in Mann R and Andrews E
-
2nd edn, John Wiley and Sons, Ltd.: Chichester, England
-
Evans SJ. Statistical methods of signal detection in Mann R and Andrews E. Pharmacovigilance (2nd edn), John Wiley and Sons, Ltd.: Chichester, England, 2007.
-
(2007)
Pharmacovigilance
-
-
Evans, S.J.1
-
6
-
-
78549253881
-
An experimental investigation of masking in the US FDA adverse event reporting system database
-
Wang HW, Hochberg AM, Pearson RK, Hauben M. An experimental investigation of masking in the US FDA adverse event reporting system database. Drug Saf 2010; 33(12): 1117-1133.
-
(2010)
Drug Saf
, vol.33
, Issue.12
, pp. 1117-1133
-
-
Wang, H.W.1
Hochberg, A.M.2
Pearson, R.K.3
Hauben, M.4
-
7
-
-
73649129173
-
Quantitative signal detection for vaccines: effects of stratification, background and masking on GlaxoSmithkline's spontaneous reports database
-
Zeinoun Z, Seifert H, Verstraeten T. Quantitative signal detection for vaccines: effects of stratification, background and masking on GlaxoSmithkline's spontaneous reports database. Hum Vaccin 2009; 5(9): 599-607.
-
(2009)
Hum Vaccin
, vol.5
, Issue.9
, pp. 599-607
-
-
Zeinoun, Z.1
Seifert, H.2
Verstraeten, T.3
-
8
-
-
78049296017
-
A potential competition bias in the detection of safety signals from spontaneous reporting databases
-
Pariente A, Didailler M, Avillach P, et al. A potential competition bias in the detection of safety signals from spontaneous reporting databases. Pharmacoepidemiol Drug Saf 2010; 19(11): 1166-1171.
-
(2010)
Pharmacoepidemiol Drug Saf
, vol.19
, Issue.11
, pp. 1166-1171
-
-
Pariente, A.1
Didailler, M.2
Avillach, P.3
-
9
-
-
26944491481
-
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
-
10
-
-
84892875680
-
-
Guideline on the use of statistical signal detection tools in the EudraVigilance data analysis system (Doc. Ref. EMEA/106464/2006 rev. 1). The guideline can be accessed at the following URL [17 May 2011].
-
Guideline on the use of statistical signal detection tools in the EudraVigilance data analysis system (Doc. Ref. EMEA/106464/2006 rev. 1). The guideline can be accessed at the following URL www.ema.europa.eu/pdfs/human/phvwp/10646406enfin.pdf [17 May 2011].
-
-
-
-
11
-
-
77952819564
-
Validation of statistical signal detection procedures in EudraVigilance post-authorisation data. A retrospective evaluation of the potential for earlier signalling
-
Alvarez Y, Hidalgo A, Maignen F, Slattery J. Validation of statistical signal detection procedures in EudraVigilance post-authorisation data. A retrospective evaluation of the potential for earlier signalling. Drug Saf 2010; 33(6): 475-487.
-
(2010)
Drug Saf
, vol.33
, Issue.6
, pp. 475-487
-
-
Alvarez, Y.1
Hidalgo, A.2
Maignen, F.3
Slattery, J.4
-
12
-
-
84892887236
-
-
General considerations for the analysis of case-control studies in Statistical methods in cancer research, Volume 1 the analysis of case-control studies. International Agency for Research on Cancer. Lyon 1980. The textbook is available on line at the following URL [17 August 2012].
-
Breslow NE, Day NE. General considerations for the analysis of case-control studies in Statistical methods in cancer research, Volume 1 the analysis of case-control studies. International Agency for Research on Cancer. Lyon 1980. The textbook is available on line at the following URL http://w2.iarc.fr/en/publications/pdfs-online/stat/sp32/SP32_vol1-0.pdf [17 August 2012].
-
-
-
Breslow, N.E.1
Day, N.E.2
-
13
-
-
0015380424
-
Components of the crude risk ratio
-
Miettinen OS. Components of the crude risk ratio. Am J Epidemiol 1972; 96: 168-172.
-
(1972)
Am J Epidemiol
, vol.96
, pp. 168-172
-
-
Miettinen, O.S.1
-
14
-
-
84884982179
-
Outlier removal to uncover patterns in adverse drug reaction surveillance - a simple unmasking strategy
-
Juhlin K, X, Ye, K, Star, G.N., Norén Outlier removal to uncover patterns in adverse drug reaction surveillance - a simple unmasking strategy. Pharmacoepidemiol Drug Saf. 2013; 22: 1119-1129.
-
(2013)
Pharmacoepidemiol Drug Saf
, vol.22
, pp. 1119-1129
-
-
Juhlin, K.1
Ye, X.2
Star, K.3
Norén, G.N.4
-
15
-
-
84892849352
-
-
Assessing the extent and impact of the masking effect of disproportionality analyses on two spontaneous reporting systems databases (submitted for publication).
-
Maignen F, Hauben M, Hung E, Van Holle L., Dogne JM. Assessing the extent and impact of the masking effect of disproportionality analyses on two spontaneous reporting systems databases (submitted for publication).
-
-
-
Maignen, F.1
Hauben, M.2
Hung, E.3
Holle, L.V.4
Dogne, J.M.5
-
16
-
-
84869870964
-
Causality assessment of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS)
-
Loughlin AM, Marchant CD, Adams W, et al. Causality assessment of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS). Vaccine 2012; 30(50): 7253-7259.
-
(2012)
Vaccine
, vol.30
, Issue.50
, pp. 7253-7259
-
-
Loughlin, A.M.1
Marchant, C.D.2
Adams, W.3
-
17
-
-
84866101389
-
Risk of fracture after bariatric surgery in the United Kingdom: population based, retrospective cohort study
-
Lalmohamed A, de Vries F, Bazelier MT, et al. Risk of fracture after bariatric surgery in the United Kingdom: population based, retrospective cohort study. BMJ 2012; 345: e5085.
-
(2012)
BMJ
, vol.345
-
-
Lalmohamed, A.1
de Vries, F.2
Bazelier, M.T.3
-
18
-
-
78751688048
-
Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership
-
Stang PE, Ryan PB, Racoosin JA, et al. Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership. Ann Intern Med 2010; 153: 600-606.
-
(2010)
Ann Intern Med
, vol.153
, pp. 600-606
-
-
Stang, P.E.1
Ryan, P.B.2
Racoosin, J.A.3
-
19
-
-
84862932391
-
The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction
-
Platt R, Carnahan RM, Brown JS, et al. The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction. Pharmacoepidemiol Drug Saf 2012; 21(Suppl S1): 1-8.
-
(2012)
Pharmacoepidemiol Drug Saf
, vol.21
, Issue.SUPPL S1
, pp. 1-8
-
-
Platt, R.1
Carnahan, R.M.2
Brown, J.S.3
-
20
-
-
84892887102
-
-
Report of CIOMS Working group VIII. Practical aspects of signal detection in pharmacovigilance. Geneva.
-
Report of CIOMS Working group VIII. Practical aspects of signal detection in pharmacovigilance. Geneva 2010.
-
(2010)
-
-
|