Signal detection methodologies to support effective safety management.
The increased focus on the safety of medical products, as well as the growing volume of available safety information, has created a need for objective quantitative approaches to supplement the medical review of individual case safety reports. Statistical algorithms can be used to identify trends and relationships in both clinical and postmarketing safety databases in support of safety signal detection. Powerful data visualization tools facilitate the medical review of the complex information generated by these methods. In addition, all these approaches need to be integrated into the daily practice of clinical safety and postmarketing pharmacovigilance.
van Manen
Robbert P
RP
Phase Forward Lincoln Technologies, Waltham, MA 02451, USA.
Fram
David
D
DuMouchel
William
W
D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards; D000818:Animals; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000592:standards; D018570:Risk Assessment; D017751:Safety Management / Q000379:methods* / Q000592:standards