The course of drug studies involves drug absorption, distribution, metabolism and elimination of compounds broken down into bi-products (metabolites). Metabolite profiling is used to assess bi-products and determine harmful effects of the accumulating compounds. According to the FDA guidelines drug developers must focus on the effects of the metabolites from early stage of development.
Metabolite profiling includes:
Identification of metabolites (Reactive metabolites &conjugation metabolites): GSH conjugation or reactive metabolites cause idiosyncratic toxicity. The tests are done at early stages of discovery using hepatocytes/microsomes to predict