Preclinical ADME studies are designed to investigate the absorption, distribution, metabolism, and excretion (ADME) of novel pharmaceuticals to support drug discovery, safety evaluation, and clinical development programs. Charles River offers custom-designed ADME studies in small and large animal species, as well as in humans, using cold or radiolabelled test materials administered by a variety of routes. Our experienced scientists routinely conduct mass balance and tissue distribution studies to determine tissue half-life, clearance rates, and potential sites of toxicity after systemic exposure. These studies are all managed using the DEBRA® Windows LIMS System to provide full electronic data collection and evaluation.
Isotopes commonly studied include Carbon-14, Tritium, and Iodine-125. We can arrange and manage custom radiosynthesis on your behalf and are able to undertake re-purification and radiodilution of radiolabelled test materials if required. ADME studies can also be integrated with metabolite profiling and identification using HPLC radiochemical detection or mass spectrometry, dose formulation analysis, and bioanalysis.
Studies conducted include:
- Plasma kinetics
- Excretion balance
- Quantitative tissue distribution (traditional methods and QWBA)
- Bioavailability
- Micro-autoradiography (to determine cellular distribution)
- Placental transfer
- Various surgical models
We have experience with a number of dose routes, including oral, intravenous, subcutaneous, transdermal, intraperitoneal, continuous infusion, intravitreal, ocular, and intratracheal, as well as via access ports into the portal vein.