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Bile salt export pump ( BSEP ) inhibition has emerged as an important mechanism that may contribute to the initiation of human drug‐induced liver injury ( DILI ). Proactive evaluation and understanding of  BSEP  inhibition is recommended in drug discovery and development to aid internal decision making on  DILI  risk.  BSEP  inhibition can be quantified using  in vitro  assays. When interpreting assay data, it is important to consider  in vivo  drug exposure. Currently, this can be undertaken most effectively by consideration of total plasma steady state drug concentrations (C ss,plasma ). However, because total drug concentrations are not predictive of pharmacological effect, the relationship between total exposure and  BSEP  inhibition is not causal. Various follow‐up studies can aid interpretation of  in vitro   BSEP  inhibition data and may be undertaken on a case‐by‐case basis.  BSEP  inhibition is one of several mechanisms by which drugs may cause  DILI , therefore, it should be considered alongside other mechanisms when evaluating possible  DILI  risk.

clinical pharmacology and therapeutics

Can Bile Salt Export Pump Inhibition Testing in Drug Discovery and Development Reduce Liver Injury Risk? An International Transporter Consortium Perspective