PK/PD Services

PK/PD studies help confirm the test article exposure and biomarker level in systemic circulation and tissues, particularly in target organs to understand the correlation of the test article exposure with its PD effect using diseased or healthy animal models. Pharmaron’s experienced team provides PK/PD services to examine several parameters in support of regulatory submissions. The quantification of the test article is conducted by the DMPK and in vitro biology teams. Toxicokinetic studies can be conducted alongside ongoing toxicology programs as well.

General PK/PD Evaluation

  • Formulation development
  • Bioavailability
  • Clearance
  • Half-life
  • Dose linearity study
  • Tissue distribution
  • Metabolite analysis
  • Biliary excretion

CNS PK/PD

  • CSF, Brain homogenate, Kp
  • Unbound level in brain, Kpuu
  • Microdialysis

Absorption

  • Ussing Chamber, Fa/Fg/Fh evaluation
  • Intraduodenal/Intracolonic/Capsule dosing
liquid in orange vial tray

Drug-Drug Interactions (DDI)

  • Pre-treatment with CYP inhibitor
  • Transporters
    • P-gp
    • BCRP
    • OATP inhibitors/transgenic animal