ABSTRACT

The use of in vitro techniques to study drug metabolism allows comparison of the metabolism of a compound across species prior to administration to humans. In addition, the use of human in vitro systems provides more relevant information on the metabolites likely to be formed in clinical studies. Therefore, interspecies comparisons of the metabolite profile of a drug candidate may assist rational selection of the most appropriate species for safety assessment studies. Finally, potential clinical interactions, i.e. the ability of a drug candidate to affect the pharmacokinetics of other coadministered therapies (induction or inhibition of drug-metabolising enzymes) can also be investigated using human in vitro systems.