Database size and power to detect safety signals in pharmacovigilance

Most regulatory agencies and pharmaceutical companies focus the majority of their pharmacovigilance on safety signal identification in large databases. GlaxoSmithKline (GSK) has > 100 drugs marketed worldwide. In order to determine which database has the highest statistical power to detect safety...

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Veröffentlicht in:	Expert opinion on drug safety 2007-11, Vol.6 (6), p.713-721
Hauptverfasser:	Hammond, Isaac W, Gibbs, Trevor G, Seifert, Harry A, Rich, Donna S
Format:	Artikel
Sprache:	eng
Schlagworte:	Adverse Drug Reaction Reporting Systems Animals Databases, Factual Drug-Related Side Effects and Adverse Reactions Humans Pharmacoepidemiology - methods pharmacovigilance safety signal detection statistical power calculation
Online-Zugang:	Volltext
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