The impact of exposure model misspecification on signal detection in prospective pharmacovigilance

Author:

van Gaalen Rolina D.1,Abrahamowicz Michal12,Buckeridge David L.1

Affiliation:

1. Department of Epidemiology, Biostatistics, and Occupational Health; McGill University; Montréal Québec Canada

2. Division of Clinical Epidemiology; McGill University Health Centre; Montréal Québec Canada

Funder

Canadian Institutes for Health Research (CIHR)

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference63 articles.

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2. Why we need observational studies to evaluate the effectiveness of health care;Black;Br Med J,1996

3. WHO Medicines - Pharmacovigilance 2012 http://www.who.int/medicines/areas/qualitysafety/safetyefficacy/pharmvigi/en/

4. FDA Guidance drug safety information - FDA's communication to the public 2007 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm

5. A critical review of methods to evaluate the impact of FDA regulatory actions;Briesacher;Pharmacoepidemiol Drug Saf,2013

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