Abstract
The assessment of risk for serious, life-threatening drug-induced liver injury (DILI)
associated with a suspect drug, biological agent, or herbal product depends on an
iterative analysis of pre- and postmarket datastreams. Because serious cases of idiosyncratic
DILI are typically rare, regulatory scientists seek strategies that accurately predict
from clinical trial data which study drugs will be likely to cause these events in
a large postmarket treatment population, e.g., through the identification of cases
that are consistent with Hy's law. This objective is only achievable if rigorous standards
in study subject monitoring, data collection and analysis of liver injury cases for
causality are followed. In the future, the development of more effective predictive
and analytic tools in preclinical and clinical testing will provide a framework to
reliably identify new agents that have hepatotoxic profiles as well as those individuals
who are susceptible to develop serious DILI.
Keywords
drug-induced liver injury - hepatotoxicity - biomarkers - clinical trials - postmarketing
drug-risk evaluation
