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
  • Physicochemical properties
    • Kinetic and thermodynamic stability
    • LogP, LogD
    • pKa
  • Metabolic stability
    • Hepatocyte stability assay
    • Microsomal stability assay
    • rCYPs
    • S9
    • Plasma stability assay
  • Permeability measurement
    • Caco-2
    • PAMPA
    • MDR1-MDCK *new offering*
  • Distribution
    • Plasma protein binding
    • Microsomal and tissue protein binding
    • Red blood cell partition (RBC)
  • Transporter assay
    • OATP1B1/HEK293
    • BCRP/MDCK
    • MDR1/MDCKII
  • Drug-drug interaction
    • Cytochrome P450 time dependent inhibition assay (single-point or IC50 shift)
    • Cytochrome P450 inhibition assay (DDI)
• In Vivo PK
  • Animal species
    • Mouse, rat, hamster, Guinea pig, Beagle dog and Cynomolgus monkey
  • 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
  • Metabolite identification, structural elucidation and determination, and quantification
  • Exploratory pre-formulation development
  • In-life dosing and sampling
  • Bioanalytical method development and qualification
  • Biological sample analysis
    • Blood, plasma, serum, bile, feces, urine, cerebrospinal fluid, other fluids and tissues

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