Preclinical ADME studies are designed to investigate the absorption, distribution, metabolism, and excretion of novel pharmaceuticals to support drug discovery, safety evaluation, and the clinical development of novel compounds. ADME studies are now an integrated part of the comprehensive safety evaluation of a novel compound. We offer a large variety of study designs tailored to your compounds’ individual needs.
Aptuit can perform ADME studies in rodent and non-rodent species as well as in man, using non-radiolabeled or radiolabeled test compounds administered by a variety of dose routes, including:
- Oral
- Intravenous (bolus and infusion)
- Subcutaneous
- Intramuscular
- Intraperitoneal
- Continuous infusion
- Intrathecal
- Intratracheal
- Portal vein access ports
Our Preclinical ADME packages typically include:
- PK studies (PK evaluation in total radioactivity, parent compound and metabolites) to provide information on the absorption, bioavailability, and elimination of a test compound.
- Mass Balance Studies in intact and bile duct cannulated animals (rodent and non-rodent) with enterohepatic re-circulation to determine the rates and route of excretion of total radioactivity and provide information on the absorption of the test compound.
- Tissue Distribution Studies (QWBPI or conventional QTD) to obtain tissue level data and assess any accumulation of a test compound in an organ or tissue. These studies can be used to support teratology studies and to investigate the uptake of the test compound into melanin pigment. Results can be used to support dosimetry calculations to determine a safe radioactive dose level in man.
- Plasma Protein Binding Studies (ultra filtration or equilibrium dialysis) to determine the degree of test compound binding to plasma proteins and thus the percentage of free, unbound test compound circulating in the body.
- Blood Cell Binding Studies to determine the degree of test compound binding to the blood cells.
Dose Administration Routes
We have experience with a number of dose routes, including:
- Oral
- Intravenous (bolus and infusion)
- Subcutaneous
- Intramuscular
- Intraperitoneal
- Continuous infusion
- Intrathecal
- Intratracheal
- Portal vein access ports
Surgical Models
Aptuit offers a variety of validated surgical models in a variety of animal species:
- Hepatic Portal Vein Cannulation
- Bile Duct Cannulation
- Vascular Cannulation
- Brain Perfusion
- Enterohepatic Recirculation
- Intestinal Access Model
New surgical models can be tailored to meet your specific needs.
Radio-isotopes and radioanalysis
Isotopes commonly studied include:
- Carbon-14
- Tritium
- Iodine-125
- Sulphur-35