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Liver injury caused by drugs is not a simple toxicity; instead, it appears as a family of toxicities that likely share common mechanisms of hepatocellular death and differ by the circumstances under which they manifest. Drug-induced hepatotoxicity can range from predictable toxicity to rare and unexpected toxicity that can be associated with acute liver failure. The current approaches for screening hepatotoxic potential are adequate for detecting predictable hepatotoxicants, but clinically significant drug-induced liver injury is often not discovered until after a drug has entered clinical testing or has already entered the market. Improvement upon the incidence of false negatives in non-clinical evaluations is essential to eradication of this toxicity, but is dependent upon both a better basic understanding of the biology of the human liver to validate extrapolation of animal results, and translational breakthroughs in the clinic to provide new endpoints for nonclinical testing. There is also an opportunity for improved prediction of clinical hepatotoxicity with better recognition of harbinger signals in pre-marketing clinical databases. However, improved prediction of relatively rare idiosyncratic hepatotoxicity will remain a challenge until there is evolution in safety assessment strategies to consider novel approaches, including models of increased susceptibility of the liver, screening for potential inhibition of hepatoprotection mechanisms, and genetic profiling of DILI-susceptible patients. The availability of databases to profile patient susceptibility could be valuable in aiding physician selection of medications for their patients.

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