ADME Studies

Radiolabeled compounds are the primary raw material/feedstock for ADME studies; using radiolabelled compounds is the primary tool for understanding metabolism and conducting non-clinical ADME studies.

Human ADME (mass balance) studies are conducted with radiolabeled compounds to track absorption, distribution, metabolism, and excretion; in vivo ADME studies are conducted with a radiolabel to provide quantitative information on rate/extent of metabolism and routes of excretion.

Radiolabeled APIs (active pharmaceutical ingredients) are required feedstock for the conduct of human ADME studies of new chemical entities, which are an important part of the drug development process.

For most ADME studies, the radiolabeled material must be diluted with unlabeled (cold) material to match the correct total dose level to be administered, indicating both labeled and unlabeled drug substance are required inputs.