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A major challenge in drug development is to accurately estimate human adverse drug effects to allow the selection and advancement of drug candidates with the best safety profile for further development. Due to species differences, safety data obtained with the routine in vivo studies with nonhuman laboratory animals do not always correctly predict human outcome. Human liver-derived systems, especially human hepatocytes, represent physiologically-relevant experimental systems for the evaluation of human adverse drug effects. The assays developed with human-based in vitro experimental systems for the assessment of two major adverse drug effects: drug-drug interactions and drug toxicity can be used routinely during drug development to select and optimize drug candidates to enhance the probability of clinical success.

Critical Human Hepatocyte-Based In Vitro Assays for the Evaluation of Adverse Drug Effects