Metabolite Identification Studies

The FDA guidance for Safety Testing of Drug Metabolites recommends that the structure of any metabolite which may represent more than 10 % of the exposure in humans should be formally elucidated.  The earlier a disproportionate metabolite is recognized and characterised in the drug development process, the lower the risk of downstream delays with better planning of clinical studies.  

The expertise and experience, in conjunction with state-of-the-art technology, are available within Arcinova to advise on the optimal approaches for completion of metabolite isolation and identification.  Where possible, isolation can be circumvented by hyphenated technologies.  The in-house mass spectrometry – Nuclear Magnetic Resonance platform not only enables identification of metabolites, but it permits quantification within a biological matrix.