PMID- 17538548
OWN - NLM
STAT- MEDLINE
DCOM- 20070911
LR  - 20220318
IS  - 0009-9236 (Print)
IS  - 0009-9236 (Linking)
VI  - 82
IP  - 2
DP  - 2007 Aug
TI  - Novel statistical tools for monitoring the safety of marketed drugs.
PG  - 157-66
AB  - Robust tools for monitoring the safety of marketed therapeutic products are of 
      paramount importance to public health. In recent years, innovative statistical 
      approaches have been developed to screen large post-marketing safety databases 
      for adverse events (AEs) that occur with disproportionate frequency. These 
      methods, known variously as quantitative signal detection, disproportionality 
      analysis, or safety data mining, facilitate the identification of new safety 
      issues or possible harmful effects of a product. In this article, we describe the 
      statistical concepts behind these methods, as well as their practical application 
      to monitoring the safety of pharmaceutical products using spontaneous AE reports. 
      We also provide examples of how these tools can be used to identify novel drug 
      interactions and demographic risk factors for adverse drug reactions. Challenges, 
      controversies, and frontiers for future research are discussed.
FAU - Almenoff, J S
AU  - Almenoff JS
AD  - Department of Epidemiology and Population Health, Safety Evaluation and Risk 
      Management, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, 
      Research Triangle Park, North Carolina, USA. june.s.almenoff@gsk.com
FAU - Pattishall, E N
AU  - Pattishall EN
FAU - Gibbs, T G
AU  - Gibbs TG
FAU - DuMouchel, W
AU  - DuMouchel W
FAU - Evans, S J W
AU  - Evans SJ
FAU - Yuen, N
AU  - Yuen N
LA  - eng
GR  - G0600621/MRC_/Medical Research Council/United Kingdom
PT  - Journal Article
PT  - Review
DEP - 20070530
PL  - United States
TA  - Clin Pharmacol Ther
JT  - Clinical pharmacology and therapeutics
JID - 0372741
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems/statistics & numerical data
MH  - *Data Interpretation, Statistical
MH  - Drug Information Services/statistics & numerical data
MH  - Drug Monitoring/*methods/statistics & numerical data/trends
MH  - Humans
MH  - Product Surveillance, Postmarketing/*methods/statistics & numerical data/trends
RF  - 74
EDAT- 2007/06/01 09:00
MHDA- 2007/09/12 09:00
CRDT- 2007/06/01 09:00
PHST- 2007/06/01 09:00 [pubmed]
PHST- 2007/09/12 09:00 [medline]
PHST- 2007/06/01 09:00 [entrez]
AID - 6100258 [pii]
AID - 10.1038/sj.clpt.6100258 [doi]
PST - ppublish
SO  - Clin Pharmacol Ther. 2007 Aug;82(2):157-66. doi: 10.1038/sj.clpt.6100258. Epub 
      2007 May 30.