Metabolic profiling of therapeutic compounds at early stages in the drug discovery process is of increasing importance. Drugs that undergo metabolism in vivo may produce pharmacologically active or chemically reactive metabolites which can produce unexpected effects or potential toxicities. The recent FDA Guidance for Industry on Safety Testing of Drug Metabolites1 highlights the relevance of in vitro metabolite profiling early in drug development, as metabolites which are unique to or disproportionate in humans may require additional toxicological studies.
In addition to an extensive panel of in vitro metabolism screening assays, Eurofins Pharma Discovery Services performs studies to thoroughly characterize the metabolic products of a drug compound in vivo or in vitro and compare metabolic profiles across species. Critical to metabolite identification studies is the use of state-of the art mass spectrometry instrumentation for sensitive and accurate detection of metabolic products and software tools to efficiently process the complex datasets that are produced from these analyses.
