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Causality assessment is a critical step in establishing the diagnosis of drug induced liver injury (DILI) during drug development. DILI may resemble almost any type of liver disease, and often presents a serious challenge to clinical investigators and drug makers. The diagnosis of DILI is largely based upon a combination of a compatible clinical course,(More)
Severe drug-induced liver injury (DILI) is a major safety concern in pharmacovigilance. It would be beneficial to develop a robust method for early detection of hepatic safety signals. The aim of this study was to assess the performance of a severity-based algorithm in detecting signals of severe DILI. We assessed a method using preferred terms (PTs) listed(More)
BACKGROUND Hepatic injury has been reported following duloxetine use. This study further examines the hepatic safety of duloxetine in a large US health insurance database. METHODS In this propensity score-matched cohort analysis in a US commercially insured population (01 August 2004 to 31 December 2010), we compared individuals with depression and(More)
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