ADME studies are designed to investigate the absorption, distribution, metabolism and excretion of novel pharmaceuticals to support discovery, lead candidate selection, preclinical testing and clinical programs. Similar ADME endpoints are critical to successful product development and registration in the veterinary medicine, chemical, and agrochemical industries. Many compounds can be rapidly screened using our rapid pharmacokinetics approach, followed by preclinical ADME and clinical pharmacokinetics for a complete ADME data package to support global regulatory submissions.
Charles River offers custom-designed ADME studies in multiple species using cold or radiolabeled test materials administered by a variety of routes. Our experienced scientists routinely conduct mass balance, PK/TK and tissue distribution studies to determine clearance routes and rates, metabolite profiles, tissue half-life 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 in compliance with GLP requirements. We can arrange and manage custom radiosynthesis on your behalf and are able to undertake re-purification and radiodilution of radiolabeled test materials if required. We routinely work with the following isotopes: 3H, 14C, 32P, 35S and 125I, and others are available on request.
- Pharmacokinetics/Toxicokinetics (PK/TK)
- Excretion, mass balance and expired air collection in rodents
- Quantitative tissue distribution (traditional method and QWBA) with dosimetry calculations
- Micro-autoradiography (to determine cellular distribution)
- Placental transfer and milk secretion
- Various surgical models, including bile duct cannulation
- Metabolite profiling and identification
- Radioactivity sample analysis
- Continuous infusion
- Portal vein (via access ports)
- Vascular access ports
- Chronic bile duct cannulation
- Intestinal cannulation
- Portal vein cannulation