Skip to main content

Drug Metabolism & Pharmacokinetics

Regulatory Services

  • Bioanalytical method development for various in-vivo and in-vitro DMPK studiesDRF/BA/001 (Non-GLP)

    This assay quantifies analyte of interest in different matrix samples of in-vivo and in-vitro studies using suitable chromatography techniques like HPLC, LCMS, GC.

    • Model

      Using suitable chromatography techniques like HPLC, LCMS, GC
    • End Point

      Robust bioanalytical method developed to estimate analyte concentration in in-vitro and in-vivo samples precisely and accurately.
    • Relevance

      To quantify analyte of interest in different matrix samples of in-vivo and in-vitro studies.
  • Pharmacokinetics studyDRF/BA/002

    This assay evaluates the pharmacokinetic parameters of analyte required to know drug absorption, distribution, metabolism and excretion profile.

    • Animal Model

      Rodent
    • End Point

      Pharmacokinetic parameters like AUC, Cmax, Tmax, Vd, Cl etc.
    • Relevance

      To evaluate the pharmacokinetic parameters of analyte required to know drug absorption,distribution,metabolism and excretion profile.
  • Bioavailability studyDRF/BA/003 (Non-GLP)

    This assay identifies the bioavailability of drug/analyte using suitable animal model.

    • Animal Model

      Rodents/Rabbit
    • End Point

      % Bioavailability will be evaluated
    • Relevance

      To identify the bioavailability of drug/analyte
  • Biodistribution studyDRF/BA/004 (Non-GLP)

    This assay identifies the biodistribution of drug/analyte in different tissues using suitable animal model.

    • Animal Model

      Rodents/Rabbit
    • End Point

      Drug distribution in different tissue will be evaluated
    • Relevance

      To identify the biodistribution of drug/analyte in different tissues
  • In-Vivo metabolism and excretion studiesDRF/BA/005 (Non-GLP)

    This assay identifies the drug metabolite formation or clearance of analyte using suitable animal model.

    • Animal Model

      Rodents
    • End Point

      Drug metabolic identified and drug clearance will be evaluated
    • Relevance

      To identify the drug metabolite and drug clearance
  • In-Vivo drug-drug interaction studiesDRF/BA/006 (Non-GLP)

    This assay identifies drug to drug interaction when taken simultaneously using suitable animal model.

    • Animal Model

      Rodents
    • End Point

      Drug inhibition and drug induction potential
    • Relevance

      To identify drug to drug interaction when taken simultaneously
  • Permeability studiesDRF/BA/007 (Non-GLP)

    This assay identifies drug permeability through cell based and non-cell based models.

    • Cell Model

      CaCo-2 cells, MDCK, PAMPA (non-cell based)
    • End Point

      Drug permeability properties.
    • Relevance

      To identify in-vitro drug permeability
  • Cytochrome P450 Inhibition/Interaction studiesDRF/BA/008 (Non-GLP)

    This assay identifies drug to drug interaction when taken simultaneously using suitable chromatography techniques like HPLC, LCMS, GC.

    • Model

      Using suitable chromatography techniques like HPLC, LCMS, GC, CYP Inhibition kits
    • End Point

      Drug inhibition potential will be evaluated.
    • Relevance

      To identify drug to drug interaction when taken simultaneously
  • Plasma protein binding studiesDRF/BA/009 (Non-GLP)

    This assay identifies binding of drug to plasma protein using ultracentrifugation, ultrafiltration or rapid equilibrium dialysis method and suitable chromatography techniques like HPLC, LCMS, GC.

    • Model

      Using Ultracentrifugation, Ultrafiltration or Rapid equilibrium dialysis method and suitable chromatography techniques like HPLC, LCMS, GC
    • End Point

      Drug plasma protein binding will be evaluated, bound and unbound fraction of drug will be evaluated.
    • Relevance

      To identify binding of drug to plasma protein
  • Dermal permeabilityDRF/BA/010 (Non-GLP)

    This assay identifies drug permeability through animal skin model or or artificial membranes using franz diffusion cell and suitable chromatography techniques like HPLC, LCMS, GC.

    • Animal Model

      Animal skin model or Artificial membrane
    • End Point

      Drug permeability potential will be evaluated.
    • Relevance

      To identify drug permeability potential through animal skin
  • Bioanalytical method validationDRF/BA/011

    This assay validates analytical methods for accurate analyte measurement.

    • Model

      Using suitable chromatography techniques like HPLC, LCMS, GC
    • End Point

      Selectivity, Specificity, Matrix effect, Calibration curve and range, Accuracy and precision, Carry-over, Dilution integrity, Stability
    • Relevance

      Confirms that the method used for the analysis is reliable, reproducible and fit for its intended purpose
  • ToxicokineticsDRF/BA/012

    This assay determines systemic exposure of compound during toxicology assessment using suitable animal model.

    • Animal Model

      Rodents/Rat
    • End Point

      Quantification of analyte/(s) in biological matrix
    • Relevance

      Determine systemic exposure of compound during toxicology assessment.