Abstract
When a new pharmaceutical is being developed, potential hepatotoxic effects are examined as part of the normal battery of assays to which compounds are routinely subjected. This is currently done in experimental animals, assuming they are a good model for humans. However, the fact that in some cases toxic effects on humans were not discovered until the first clinical trials because significant interspecies drug metabolism differences have stimulated the use of human-derived cells for the detection of potential hepatotoxicity at early stages of drug development. Cellular models show ideal advantages for preliminary screening of hepatic effects and drug metabolism studies: they are applicable at first stages of drug development; only a small amount of the compound is needed for the assays; they can be of help in selecting the best animal model for metabolic and pharmacokinetic studies and, if human hepatocytes are used, they can provide a specific and direct information about potential effects of the compound on the human liver. Moreover, drug-drug interactions can be easily investigated under conditions that would be ethically unacceptable with human beings.
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