Drug Metabolism and Pharmacokinetics Research

///Drug Metabolism and Pharmacokinetics Research
Drug Metabolism and Pharmacokinetics Research 2017-07-04T10:25:24+00:00

Drug Metabolism and Pharmacokinetics Research

Saving Our Troops: An Efficacy Model for Platelet Replacement Products
The best way to support our troops is to help them come home healthy. Over 52,280 United States service members were wounded in action during the conflicts in Iraq and Afghanistan. Many of these injuries were associated with blood loss. To prevent excessive blood loss, researchers are developing novel platelet replacement products.

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Expertise, experience, and a broad range of specialized capabilities

The experienced scientific team at MPI Research who conduct a wide range of studies in support of both discovery and development programs. With strong credentials and experience in chemistry, biology, pharmacology, toxicology, and metabolite identification, our research team performs DMPK studies with a variety of animal models in a dedicated, quality-assured GLP environment that includes

  • Large capacity to conduct in vivo PK, mass balance, excretion, and tissue distribution studies
  • Extensive experience with all relevant animal species (mouse, rat, dog, swine, nonhuman primate, etc.)
  • Creation and management of Sponsor-owned colonies of animals
  • Fully integrated bioanalytical and pharmacokinetic analysis
  • Broad Nuclear Regulatory Commission (NRC) licensing for a range of radiolabels and designs
  • Custom studies for absorption, biodistribution, metabolism, and excretion (ADME)
  • Industry-leading laboratory software and data-management tools, and experience with all laboratory species
  • Rapid turnaround of PK studies: five days from startup to summary reports

Pharmacokinetic

  • Pharmacokinetics (dose-to-data in 72 hours)
  • Screening of multiple compounds
  • Cassette dosing
  • Dose range finding (DRF) and maximum tolerated dose (MTD)
  • Lead optimization
  • Bioequivalence
  • Modeling services using the Phoenix WinNonlin® platform

ADME

  • Pharmacokinetics and pharmacodynamics
  • Tissue distribution
  • Rates and routes of excretion
  • Biliary excretion and hepatobiliary recirculation
  • Animals (rodents, dogs, and nonhuman primates) surgically prepared for vascular access and bile collection
  • Traditional dissection and analysis
  • Quantitative Whole-Body Autoradiography (QWBA), traditional two-dimensional and three-dimensional
  • Positron Emission Tomography (PET)
  • Single Photon Emission Tomography (SPECT)
  • Radiochromatographic profiling and UV or MS metabolite profiling
  • High Performance Liquid Chromatography (HPLC) with UV and flow-through radioactivity detection
  • Structure elucidation of major metabolites
  • Thermo LTQ Orbitrap Discovery™ high-resolution and API 5000 tandem mass spectrometers (MS)
  • Protein binding
  • Metabolite profile and metabolite identification
    • Enzymes, cell fractions (microsomes), cells (hepatocytes), tissues, and in situ preparations
  • Reactive metabolites
  • Stability in microsomes, S9 fraction, and/or hepatocytes
  • Plasma/whole blood partitioning
  • Elucidation of metabolic pathways
  • Drug-drug interaction (DDI) studies (if needed)
    • CYP activity profiles, CYP inhibition and induction
    • Non-CYP metabolism
  • Permeability and drug transport (influx and efflux)
  • Permeability
  • Inhibition
  • Substrates
  • Whole blood partitioning
  • Plasma binding
  • Tissue binding
  • Receptor binding
  • CellCiphr Premier®
  • eCiphr® cardiovascular
  • eCiphr® neurological
  • Ocular irritation
  • Skin irritation, absorption, and sensitization
  • Gene induction
  • Dermal penetration in multiple species
  • Melanin binding determination in Long-Evans rats and Dutch-Belted rabbits
  • Dosimetry and preparation of dosimetry memo to support human clinical ADME studies
  • Full ocular tissue distribution determination by dissection in multiple species