WHITE PAPER: Evaluation of an Alternative System for In Vitro Metabolite Profiling

Abstract

Two of the most critical aspects in characterization studies are understanding new drug metabolism and identifying its metabolites. A metabolic profile of the new drug is established to assess the potential toxicity of the drug itself or its metabolites, drug-drug interactions, and for regulatory bodies to determine whether the drug should progress to clinical trials. Currently, in vitro metabolic methods involve the analysis of biotransformed compounds from cell-free and hepatocyte systems. This white paper aims to discuss each of the commonly used systems and address limitations with highlights from a case study of the well-characterized acid reflux drug, omeprazole. 

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