Metabolite profiles (species comparison)
Cross-species metabolite profiling and identification (MetID) studies help to understand the biotransformation of the test article. This information can be applied to understand the potential for enzymatic-based mechanisms of clearance across species. These data can be used help determine the appropriate species for nonclinical safety studies to ensure compliance with the ICH M3(R2)/MIST guidelines.
The FDA recommends the use of in vitro interspecies metabolic comparisons at an early stage in the drug development process. Knowledge about the metabolism of a compound is also important from a drug discovery perspective. In vivo metabolism study results will either confirm the results obtained from the in vitro studies or reveal quantitative and/or qualitative differences in metabolism across species.