Online Catalog
A collection of nonclinical studies & assays; customization is possible.

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.

Molecule or Product Type

Biologics, Small Molecule



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