Choosing Thresholds for Statistical Signal Detection with the Proportional Reporting Ratio-Reference-Cited by-同舟云学术

Choosing Thresholds for Statistical Signal Detection with the Proportional Reporting Ratio

Published:2013-06-11 Issue:8 Volume:36 Page:687-692
ISSN:0114-5916
Container-title:Drug Safety
language:en
Short-container-title:Drug Saf

Author:

Slattery Jim,Alvarez Yolanda,Hidalgo Ana

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Toxicology

Link

http://link.springer.com/content/pdf/10.1007/s40264-013-0075-1.pdf

Reference12 articles.

1. Finney DJ. Statistical logic in the monitoring of adverse reactions to therapeutic drugs. Methods Inf Med. 1971;10:237–42.

2. 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):475–87.

3. Council Regulation (EEC) No 2309/93 of 22 July 1993 laying 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. http://ec.europa.eu/health/files/eudralex/vol-1/reg_1993_2309/reg_1993_2309_en.pdf . Accessed 16 May 2013.

4. MedDRA and MSSO. http://www.meddramsso.com . Accessed 18 Dec 2012.

5. European Medicines Agency. EudraVigilance. http://eudravigilance.emea.europa.eu/highres.htm . Accessed 18 Dec 2012.

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