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 12,000 square-foot/3657.6 meter 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-naive colonies of canines, nonhuman primates, and pigs support individual pharmacokinetic screening studies.  Additionally, MPI Research maintains significant naive colonies, allowing rapid study initiation. MPI Research also maintains Sponsor-owned canine and 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 utilized including oral (gavage and capsule), topical, intramuscular, subcutaneous, intratrachael, intravenous, and other routes as requested.

Services/Capabilities

• Routinely conduct discovery pharmacokinetic, ADME mass balance, and pharmacokinetic studies using :
  • ¹⁴C, ³H, ³⁵S, ¹²⁵I, and other isotopes upon request, or nonradiolabeled compounds
  • Metabolism cages for mice, rats, canines, pigs, and nonhuman primates
  • CO₂ chamber for rats, canines, and nonhuman primates
  • Full tissue extraction
  • Packard TriCarb 2900TR Liquid Scintillation Analyzers
  • Waters HPLC, equipped with IN/US Systems Radio-HPLC Detectors
  • Packard Oxidizers
  • LabLogic’s “Debra” software
  • Mouse models providing rapid drug disposition and metabolite profiles with small amounts of drug
  • Animal models utilized include: rats, mice, rabbits, dogs, non-human primates, and swine (minipigs, micropigs, and farm pigs)
• Site-specific absorption and metabolism studies including duodenal, portal vein, hepatic vein or artery, and other sites as requested using surgical and nonsurgical techniques
• In vivo services
  • Dosing of animals
  • Formulation analysis
  • Collection and processing of samples for analysis
• Support for bioanalysis and pharmacokinetic modeling
• Standard and customized pharmacokinetic studies analyzing blood/plasma concentrations, bioavailability, absorption, and clearance along with pharmacokinetic analysis
• Mass balance (excretion, expired air)
• Quantitative tissue distribution (by individual tissue oxidation or whole-body autoradiography)
• Dermal penetration in swine
• Metabolic profiling by HPLC with radioactivity/UV detection and LC-MS/MS

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. 1753.

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