Integrated DMPK Studies PDF print email

Biotranex provides integrated DMPK package studies to support successful IND and NDA filings:

  • Integrated DMPK studies in drug discovery
    • Solubility
    • Permeability (Caco-2, MDCKII and PAMPA)
    • Protein binding
    • Hepatocyte uptake
    • Metabolic stability in plasma, liver fractions, or hepatocytes
    • Soft-spot identification and quantification
    • CYP inhibition and induction
    • Transporter profiling and inhibition
    • Identification of GSH-adduct formation
    • Identification of major metabolic enzymes
    • Identification and semi-quantification of metabolites in microsomes and hepatocytes of different species
    • Metabolite profiling in animal plasma
  • Integrated DMPK studies in drug development
    • Metabolite profiling (identification and semi-quantification) in plasma of FIH studies
    • Isolation and structural characterization of metabolites
    • Mass balance studies in animals and humans using radiolabels
    • Metabolite profiling in plasma, urine, bile, feces and tissues
    • CYP, UGT, and SULT reaction phenotyping
    • CYP inhibition and induction
    • Transporter inhibition and identification
    • Determination of Km, Vmax, IC50, Ki, Kinact
    • Elucidation of metabolic pathways
    • Mechanistic drug development studies

 

 

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