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 DMPK Services

 

PK/ADME Studies
  • PK/TK sample analysis (LC-MS/MS)
  • property characterization (F, T1/2, Cmax, Tmax, CL, Vss, AUC), typically in mouse, rat, dog and monkey
  • Dose proportionality
  • Assessment of hepatic first pass effect and biliary excretion
  • PK/PD relationship
  • Drug permeability assay (CaCO2)
  • Metabolic stability (microsomes, S9 and hepatocytes)
  • CYP inhibition (IC50, Ki) for DDI
  • CYP reaction phenotyping
  • Plasma protein binding assays
  • Plasma satbility evaluation
Preliminary Toxicity Assessment
  • Rising dose 7-day and 14-day tox studies (mice / rats)
  • Enzyme assays
  • LD50 and MTD study
  • Dermal toxicity (rabbits)
  • Blood chemistry and histology
In vitro Studies
  • Enzyme assays
  • Cell culture and assays
  • Gene expression analysis
  • Mechanism-based inhibitor testing

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