Validation of statistical signal detection procedures in eudra vigilance post-authorization data: A retrospective evaluation of the potential for earlier signalling
ARTICLE;
CONSENSUS;
DRUG DETERMINATION;
DRUG SAFETY;
DRUG SURVEILLANCE PROGRAM;
PRIORITY JOURNAL;
RETROSPECTIVE STUDY;
SCREENING;
SIGNAL DETECTION;
SIGNAL TRANSDUCTION;
STATISTICAL ANALYSIS;
VALIDATION STUDY;
ADVERSE DRUG REACTION REPORTING SYSTEMS;
DATABASES, FACTUAL;
DRUG AND NARCOTIC CONTROL;
DRUG TOXICITY;
EUROPEAN UNION;
HUMANS;
MODELS, STATISTICAL;
PRODUCT SURVEILLANCE, POSTMARKETING;
TIME FACTORS;
The rules governing medicinal products in the European Union
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The rules governing medicinal products in the European Union. Notice to applicants and regulatory guidelines for medicinal products for human use. Vol.2 [online]. Available from URL: http://ec.europa.eu/enterprise/sectors/ pharmaceuticals/documents/eudralex/vol-2/index-en.htm [Accessed 2010 Apr 13]
The rules governing medicinal products in the European Union [online] [Accessed 2010 Apr 13]
The rules governing medicinal products in the European Union. Guidelines on pharmacovigilance for medicinal products in human use. Vol.9A [online]. Available from URL: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol- 9/pdf/vol9a-09-2008.pdf [Accessed 2010 Apr 13]
A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions
VanPuijenbroek E, Bate A, Leufkens HGM, et al. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf 2002; 11: 3-10
European Medicines Agency [online] [Accessed 2010 Apr 13]
European Medicines Agency. EudraVigilance: pharmaco-vigilance in the European economic area [online]. Available from URL: http://eudravigilance.emea. europa.eu/highres. htm [Accessed 2010 Apr 13]
Council regulation (EEC) no. 2309/93 of 22 July 1993 lay-ing down community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European agency for the evaluation of medicinal products [online] [Accessed 2010 Apr 13]
Council regulation (EEC) no. 2309/93 of 22 July 1993 lay-ing down community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European agency for the evaluation of medicinal products [online]. Available from URL: http://ec.europa.eu/enterprise/pharmaceuti cals/eudralex/vol-1/reg-1993-2309/ reg-1993-2309-en.pdf [Accessed 2010 Apr 13]
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Use of proportional report-ing ratios (PRR) for signal generation from spontaneous adverse drug reaction reports
Evans SJW, Waller P, Davis S. Use of proportional report-ing ratios (PRR) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf 2001; 10: 483-486
European Medicines Agency. EudraVigilance Expert Working Group [online] [Accessed 2010 Apr 13]
European Medicines Agency, EudraVigilance Expert Working Group. Guideline on the use of statistical signal detection methods in the EudraVigilance data analysis system (EMEA/106464/2006 rev.1) [online]. Available from URL: http://www.emea.europa.eu/pdfs/human/phvwp/10646406enfin.pdf [Accessed 2010 Apr 13]
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 Inf J 2007; 41: 633-643
