To obtain information on the number and type (phase I and phase II) of metabolites and the abundance of metabolites produced in vitro.
The extent of metabolic profiling studies can be highly variable and depends on the requirements of the Sponsor.
The in vitro metabolic profiling is generally performed in a system containing liver microsomes, specific systems or hepatocytes. Tests applying special systems, e.g. supersomes or specific isoenzymes are also possible. Only phase I metabolites will be detected in the samples of a microsomal model, while both phase I and phase II metabolites can be studied in samples originating from a system using hepatocytes
In vitro metabolic profiling:
Non-labeled material can be applied for in vitro metabolic profiling tests. Metabolites of samples of non-labeled test item are analyzed by LC/MS/MS. LC/MS/MS provides additional information concerning the molecular weight and structure of the metabolites produced.
In vitro tests are most suitable for the comparison of the species since microsomal preparations and hepatocytes of many species are available. Eventual species specific metabolites can also be detected.