XenoFinder offers comprehensive capabilities for conducting ¹⁴C- and ³H-radiolabeled ADME studies in mice, rats, dogs, monkeys, and humans. These studies are critical to drug development, providing definitive data on the fate of a compound in both preclinical species and humans. They are essential for regulatory submissions, enabling a thorough understanding of systemic exposure, metabolic pathways, and routes of excretion. The following are key examples of radiolabeled ADME studies:
·The non-human primate radiolabeled ADME model is a highly advanced and specialized platform that provides critical insights into the ADME properties of emerging drug modalities, including antibody-drug conjugates (ADCs) and peptide-based therapeutics. This model is especially valuable for predicting ADME behavior in humans.
·The use of radiolabeled compounds allows for precise quantification of total drug-related material, even when metabolites are unknown or present at trace levels. This is crucial for identifying and characterizing metabolites of concern, evaluating bioavailability, and determining mass balance.
·Radiolabeled ADME studies in humans are often pivotal for regulatory approval. Agencies such as the FDA and EMA require these studies to assess the safety of major human metabolites and ensure that the pharmacokinetic profile is fully understood.