ADME studies and metabolite identification

ADME studies investigate the absorption, distribution, metabolism and excretion (ADME) of a radiolabeled compound. 

The route of administration is often identical to the intended clinical route of administration (pharmaceutical), the intended application (veterinary), or to support the safety evaluation of an agricultural protection product. Intravenous administration is also often included, where possible, to allow assessment of the absolute bioavailability of the test material. 

Metabolite profiling and identification (MetID) studies help to understand the biotransformation of the test article.This information can be applied to determine enzymatic-based mechanisms of clearance, parse the presence of potential active metabolites and observe disproportionate or unique metabolites between species. Further identification of metabolites can be undertaken by NMR. 

Data from these studies are critical in meeting regulatory guidance.