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Drug Metabolism & Pharmacokinetics
 

In support of the discovery and development programs of its Sponsors, MPI Research conducts a wide range of studies in its Drug Metabolism and Pharmacokinetics (DMPK) department. A new 14,000 ft2 (4267 m2) laboratory, dedicated solely to DMPK research, allows specialization and streamlining of  scheduling, implementation, and reporting processes.

Discovery pharmacokinetic studies are typically begun within 5 to 7 days of receipt of the test article and signed protocol. Likewise, a letter summarizing results following study completion is usually received within 5 to 7 days.

Non-naïve colonies of bile duct cannulated dogs and Nonhuman primates are maintained to support ADME studies. Additionally, MPI Research maintains significant naive colonies, allowing rapid study initiation. MPI Research also maintains Sponsor-owned canine and nonhuman primate colonies; these colonies have supported high-throughput in vivo drug candidate screening programs for both large and small pharmaceutical Sponsors needing to perform large numbers of pharmacokinetic/bioanalytical studies annually.

In addition to canines and nonhuman primates, other animal models utilized include rats, mice, rabbits, micropigs, farm pigs, and minipigs. Multiple routes of administration are employed including oral (gavage and capsule), topical, intramuscular, subcutaneous, intratrachael, intravenous, and other routes as requested.

Services/Capabilities

  • Animal models: rats, mice, rabbits, dogs, non-human primates, micropigs, minipigs, and farm pigs
  • Routes of administration: oral (gavage and capsule), topical, intramuscular, subcutaneous, intratrachael, and intravenous primarily; other routes as requested
  • Site specific absorption and metabolism studies including duodenal, portal vein, hepatic vein or artery and other sites as requested utilizing surgical and non-surgical techniques
  • In vivo services
    • Dosing of animals
    • Collection and processing of samples
    • Analysis of samples in-house or shipment of samples to Sponsor-designated facilities
  • Rapid study startup for discovery pharmacokinetic studies (generally within 5-7 days from the time of receipt of signed protocol and test article)
  • Pharmacokinetic studies with a focus on blood/plasma concentrations, bioavailability, and clearance
  • Expeditious reporting of results (letter report generally within 5-7 days following study completion)
  • Bioanalytical and pharmacokinetic support available
  • Mass Balance (excretion and expired air)
  • Quantitative tissue distribution (by individual tissue oxidation or whole-body autoradiography)
  • Bile-duct cannulation (colonies maintained in dogs, monkeys, and rats upon request)
  • Dermal penetration in swine
  • Metabolic profiling by HPLC with radioactivity/UV detection, and mass spectrometry (triple quad/orbit trap)
  • Our experienced staff can provide customized study designs to suit Sponsor needs

For more detailed information about the drug metabolism and pharmacokinetic services offered by MPI Research, please contact DMPK@mpiresearch.com or call 269.668.3336, Ext. 1052.

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