Affiliation: GlaxoSmithKline Research and Development
- Novel statistical tools for monitoring the safety of marketed drugsJ S Almenoff
Department of Epidemiology and Population Health, Safety Evaluation and Risk Management, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Research Triangle Park, North Carolina, USA
Clin Pharmacol Ther 82:157-66. 2007..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...
- Innovations for the future of pharmacovigilanceJune S Almenoff
Safety Evaluation and Risk Management, GlaxoSmithKline, Research Triangle Park, NC 27709, USA
Drug Saf 30:631-3. 2007..In summary, the implementation of OSM provides new tools and efficient processes to advance the science of pharmacovigilance...
- Disproportionality analysis using empirical Bayes data mining: a tool for the evaluation of drug interactions in the post-marketing settingJune S Almenoff
GlaxoSmithKline, Global Clinical Safety and Pharmacovigilance, Five Moore Drive, PO Box 13398, 5.4214.4C, Research Triangle Park, NC 27709-3398, USA
Pharmacoepidemiol Drug Saf 12:517-21. 2003
- Perspectives on the use of data mining in pharmaco-vigilanceJune Almenoff
GlaxoSmithKline, Research Triangle Park, North Carolina, USA
Drug Saf 28:981-1007. 2005..The availability of a publicly accessible global safety database, which is updated on a frequent basis, would further enhance detection and communication about safety issues...
- Comparative performance of two quantitative safety signalling methods: implications for use in a pharmacovigilance departmentJune S Almenoff
Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Research Triangle Park, North Carolina 27709 3398, USA
Drug Saf 29:875-87. 2006....
- Evolving paradigms in pharmacovigilanceWendy Brewster
GlaxoSmithKline, Global Clinical Safety and Pharmacovigilance, Harlow, UK
Curr Drug Saf 1:127-34. 2006..In summary, the information outlined in this paper provides a valuable benchmark for risk management and pharmacovigilance in pharmaceutical development...
- Association of asthma therapy and Churg-Strauss syndrome: an analysis of postmarketing surveillance dataWilliam DuMouchel
AT and T Labs Research, Florham Park, New Jersey, USA
Clin Ther 26:1092-1104. 2004..Churg-Strauss syndrome (CSS), also known as allergic granulomatous angiitis (AGA), is a rare vasculitis that occurs in patients with bronchial asthma. The nature of the association of CSS with various asthma therapies is unclear...