Metabolite profiles (species comparison)

Study

Environmental, Metabolism, Animal, Metabolite Identification

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

Models

Bovine, Canine, Feline, Guinea Pig, Hamster, Human, Marmoset, Mini-pig, Mouse, Rabbit, Rat

Regulatory

IND & CTA

Industry Market

Pharma

Phase

Discovery, Nonclinical

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