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Drug Discovery at BioDuro (Icon)

DMPK

High quality in vitro and in vivo studies to help prediction of therapeutic outcomes. Integration with early formulation development studies that enable more accurate scaling of results to humans.

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Overview

BioDuro provides insightful Drug Metabolism and Pharmacokinetic services through its unique position as a drug discovery and development organization. With strong credentials and experience in chemistry, biology, pharmacology, and formulation development, the DMPK team performs studies with a wide variety of animal models in an AAALAC accredited and GLP-like environment.

BioDuro Advantage

  • Integration with drug discovery and drug development teams
  • 5-10 day project turnaround time
  • Custom studies for ADME
  • AAALAC accredited animal facilities
  • GLP-like laboratory environment
  • Dedication to animal welfare

Services

  • In Vitro ADME
  • In Vivo Rodent PK/TK
    • Species:
      • Mice (CD-1, C57BL/6, etc), Rats (Sprague Dawley, Wistar, Wistar-Han, etc), Hamsters, Guinea pigs
    • Administration Routes:
      • Oral (PO), Intravenous (IV bolus, infusion, cassette-dosing), Intraarterial (IA), intramuscular (IM), Intraperitoneal (IP), Intratracheal (IT), Subcutaneous (SC), Transdermal (TD)
    • Surgical Techniques:
      • Bile-duct cannulation (BDC), Jugular cannulation (JVC), Portal vein cannulation (PVC), Carotid artery cannulation (CAC), JVC/CAC, JVC/PVC
    • Biological Matrices:
      • Blood plasma/serum, bile/urine/feces, cerebrospinal fluid (CSF), bone marrow, tissue (liver, brain, kidney, etc) or tumor specimens
    • Mouse PK: Serial bleeding
    • Cassette-dosing
    • Excretion pathways
    • Turnaround Time:
      • 5-10 working days
  • Dog and Monkey PK
    • Dog PK:
      • In-house dog colony: 48 Beagle dogs
      • Administration Routes: PO and IV (bolus, infusion), SC
      • Crossover or Non-crossover; fast/fed (food effect); PK/PD evaluation
    • Monkey PK:
      • Off-site NHP colony: 32 male Cynomologus monkeys
      • Partner: Dosing and Sampling
      • BioDuro: Formulation prep, monitoring for dosing and sampling, bioanalytical method development and sample analysis, report writing
      • Excretion pathways
    • Turnaround time:
      • 10 working days for non-naive dogs & monkeys
  • Exploratory Toxicity (MTD, DRF) in Rodents (In-house) and in Dogs/Monkeys (With Partners)
    • Maximum toleration dose
    • Dose ranging finding/toxicokinetics (7, 14 and 28 days)
      • Clinical observation
      • Clinical pathology (serum chemistry, hematology and coagulation)
      • Histopathology (samples analyzed by partners)
    • Turnaround Time
      • 10 working days for TK and clinical pathology
      • 5-6 weeks for histopathology report
  • Deliverables
    • Bioavailability
    • PK parameters
    • Tissue distribution
    • Maximum toleration dose
    • Dose proportionality
    • Excretion pathways: biliary vs urinary
    • Vehicle selection
    • Blood Brain Barrier (BBB)
    • PD biomarkers
  • Capacity
    • 60 IV/PO PK/week
  • Pre-formulation screening
    • ~2,000 compounds/year
  • Other species available with Partners
    • Ferrets
    • Mini-pigs
    • Rabbits

Capabilities

  • PO, IV, SC, IP, IN; IV/PO cassette dosing
  • Multiple dosage routes
  • Multiple cannulation models
  • Liver microsome/hepatocyte stability
  • CYP phenotyping
  • Metabolite ID
  • Caco-2
  • PAMPA
  • CYP inhibition assay
  • Time dependent inhibition
  • GSH trapping assay

Equipment

  • LC-MS/MS
    • API-6500+
    • API-5500
    • API-4000 QTRAP
    • API 4500 QTRAP
    • API 4000
  • UPLC/HPLC
    • Shimadzu LC-30AD
    • Waters H-Class
    • Shimadzu LC-20AD
 
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