Metabolism
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Discovery Support Services
During the discovery phase, metabolism studies provide information for the prediction of in vivo behavior of molecules, thereby helping in the selection of candidates from a lead series.
Covance provides a comprehensive range of high-volume discovery screens and models. Our metabolism scientists routinely develop ADMET screening programs, allowing you to improve your turnaround time in candidate selection and proceed confidently into development.
- In vivo metabolism screening in microsomes, S-9 or hepatocytes
- In vivo absorption models (Caco-2, MDCK)
- In vitro cytochrome-P450 inhibition screening
- In vitro plasma protein binding
- In vitro pharmacokinetic screening (rodent, canine, nonhuman primate)
- High throughput LC-MS/MS quantitation
Development Services
For compounds in development, ADME studies provide data for the validation of toxicology species, prediction of human pharmacokinetics, and assessment of drug-drug interaction potential.
Our metabolism scientists can design, initiate and conduct all aspects of your ADME studies. As the premier metabolism provider to the pharmaceutical and biotechnology industries, Covance has conducted thousands of GLP ADME studies to support IND, CTA and NDA submissions.
Our global capacity provides you with a wider selection of study types and rapid study starts that allow us to be flexible to meet your schedule.
- Identification of specific cytochrome-P450 enzymes involved in metabolism
- Cytochrome-P450 inhibition (IC50 and Ki)
- Species comparison of in vitro metabolism in microsomes and hepatocytes
- Ex vivo cytochrome-P450 induction (rodent, dog, primate)
- In vitro cytochrome-P450 induction in fresh human hepatocytes
- In vitro and ex vivo plasma protein binding species comparison
- In vitro and ex vivo blood cell partitioning
- In vitro dermal absorption in human and animal skin
- Definitive pharmacokinetics and formulation testing in animals
- In vivo product release testing
- Excretion and mass balance
- Placental and lacteal transfer (mouse, rat)
- Distribution by quantitative whole-body autoradiography (QWBA) and excision
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- Expired CO2 collections (mouse, rat, hamster)
- Microhistoautoradiography
- Biliary excretion and enterohepatic cycling (rodent, dog, primate)
- Portal vein cannulation (dog)
- Dosimetry calculations for human radiolabeled studies
- Human metabolism and excretion (Phase I clinical study)
- Metabolite profiling and structural identification (HPLC-MS/MS with accurate mass determination, and HPLC-NMR)
- Specialized routes of administration such as: intravenous infusion, dermal, ocular, intravitreal, sub-tenon, inhalation, intravesicular
- Studies with different isotopes (14C, 3H, 125I, 35S)
- Studies in many animal species (mouse, rat, hamster, ferret, rabbit, dog, primate, minipig)
- GM and tumor animal models available
- ADME in livestock and avian species to support Agrochemical and Animal Health product development
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Pharmacokinetics and Pharmacodynamics Analyses
- Investigations of absorption and clearance
- Compartmental/noncompartmental analysis (WinNonlin™)
- Bioavailability/bioequivalence
- PK/PD analysis
- Statistical analysis (SAS®)
- Allometry
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WinNonlin is a registered trademark of Pharsight Corporation.
SAS is a registered trademark of SAS Institute Inc. |
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