Stratification for spontaneous report databases

Drug Safety

Volumn 31, Issue 11, 2008, Pages 1049-1052

  Evans, Stephen J W ^a  

^a LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

Author keywords

Adverse reaction monitoring; Data collection; Postmarketing surveillance

Indexed keywords

COMPUTER SIMULATION; DATA BASE; DRUG SURVEILLANCE PROGRAM; FALSE POSITIVE RESULT; FOOD AND DRUG ADMINISTRATION; MEDICAL DOCUMENTATION; MEDICAL INFORMATION SYSTEM; NOTE; PRIORITY JOURNAL; WORLD HEALTH ORGANIZATION;

BAYES THEOREM; DATA INTERPRETATION, STATISTICAL; DATABASES, FACTUAL; HUMANS; PHARMACEUTICAL PREPARATIONS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VACCINES;

EID: 53549103044     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200831110-00009     Document Type: Note

References (6)

1. Woo EJ, Ball R, Burwen DR, et al. Effects of stratification on data mining in the US Vaccine Adverse Event Reporting System (VAERS). Drug Saf 2008; 31 (8): 667-74
2. Hopstadius J, Norén GN, Bate A, et al. Impact of stratification in adverse drug reaction surveillance. Drug Saf 2008; 31 (11): 1035-48
3. Hauben M, Reich L. Safety related drug-labelling changes: findings from two data mining algorithms [published erratum appears in Drug Saf 2006; 29 (12): 1192]. Drug Saf 2004; 27 (10): 735-44
4. Almenoff JS, Pattishall EN, Gibbs TG, et al. Novel statistical tools for monitoring the safety of marketed drugs. Clin Pharmacol Ther 2007; 82 (2): 157-66
5. Wang R, Lagakos SW, Ware JH, et al. Statistics in medicine: reporting of subgroup analyses in clinical trials. N Engl J Med 2007; 357 (21): 2189-94
6. Hopstadius J. Methods to control for confounding variables in screening for association in the WHO drug safety database [master's thesis]. Uppsala: Department of Mathematics, Uppsala University, 2006