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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 Pharmacokinetics services through its unique position as a drug discovery and preclinical 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 studies in an AAALAC accredited and GLP-like environment and a full in vitro ADME assay platform

BioDuro Advantage

  • Assay platform spanning from discovery to preclinical development
  • The state-of-art and GLP-like bioanalytical laboratory
  • AAALAC accredited animal facilities
  • Over 14-year history of execution, flexibility and timeliness
  • Rapid turnaround time
  • Cost-effective
 

In Vitro ADME

Physicochemical properties

Metabolic stability

Permeability measurement

Distribution

Transporters

  • P-gp/Caco-2
  • BCRP/Caco-2
  • MDR1/MDCK
  • BSEP/vesicles
  • MRP2/vesicles
  • OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1, MATE2K/HEK293

Drug-drug interactions

Metabolite identification and profiling

  • Metabolite identification in liver microsomes and other in vitro metabolic reaction systems
  • Metabolite identification in plasma and other fluids or tissues from PK or TK studies
  • Reactive metabolite GSH trapping

Reaction phenotyping

  • CYP450 reaction phenotyping (rhCYP and chemical inhibition)
  • UGT reaction phenotyping

Turnaround Time

  • 5 working days except metabolite identification and uptake transporter (10 working days), and CYP450 induction (15 working days)
 

IN VIVO PK/PK

Rodents

  • 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), OA (oropharyngeal aspiration), Intrarectal (IR), intranasal (IN), single or multiple doses
  • 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

Large Animal PK/TK

  • Dogs:
    • In-house dog colony: 48 Beagle dogs
    • Administration Routes: PO and IV (bolus, infusion), SC, IM
    • Crossover or Non-crossover; fast/fed (food effect); PK/PD evaluation
  • Monkeys:
    • Off-site NHP colony: 32 Cynomologus monkeys (Rhesus monkeys also available)
    • Partner: Dosing and sampling
    • BioDuro: Formulation preparation, 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) (samples analyzed by partners)
    • 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)
  • Drug-drug inhibitory interaction
  • PD biomarkers

Capacity

  • 60 IV/PO PK/week

Pre-formulation screening

  • ~2,000 compounds/year

Other species available with Partners

  • Ferrets
  • Mini-pigs
  • Rabbits

IND-enabling ADME/PK studies (US and China FDA Filing)

 

Equipment

  • LC-MS/MS
    • API-6500+
    • API-5500
    • API-4000 QTRAP
    • API 4500 QTRAP
    • API 4000
    • Q-Exactive Plus (HRMS)
  • UPLC/UHPLC/HPLC
    • Waters H-Class
    • Shimadzu LC-30AD and LC-20AD
    • UltiMate 3000

 

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