The FDA guidance for industry in the premarketing clinical evaluation of drug-induced liver
injury (DILI) is the most specific regulatory guidance currently available and has been useful …

Abstract Analysis of liver safety data has to be multivariate by nature and needs to take into
account time dependency of observations. Current standard tools for liver safety assessment …

A workshop was convened to discuss best practices for the assessment of drug-induced
liver injury (DILI) in clinical trials. In a breakout session, workshop attendees discussed …

The subject of drug-induced liver injury (DILI) has been evolving for decades. While various
guidance and other documents have been produced to help identify and manage DILI in the …

Prompted by approval in 1997 of troglitazone and bromfenac, two drugs that promptly began
to show serious and sometimes fatal liver toxicity, we began at the Food and Drug …

There has been a substantial interest in drug-induced liver injury (DILI) recently. National
Institutes of Health has sponsored a multicenter study in the USA for the last 10 years, which …

The European Association for the Study of the Liver has produced extensive guidelines for
the investigation and management of drug-induced liver injury. Here, we provide a …

Background and aim The occurrence of drug induced liver injury (DILI) is the most common
reason of post-marketing withdrawals. DILI in humans is difficult to predict using in vitro …

Drug-induced live injury (DILI) has been a major cause of drug withdrawal, nonapproval,
and regulatory action in the last 50 years. In most cases, drugs that caused severe DILI did …

Severe drug-induced liver injury is a relatively rare but important public health problem.
Extrapolating the incidence of this problem from clinical treatment trials is confounded by a …