Optimising the dose and dosing regimen is a key step in the overall development program

ICON provides a comprehensive range of pharmacokinetic (PK) and pharmacodynamic (PD) modelling and simulation, either as individual components or as part of an integrated package.Our expertise in the application and presentation of PK and PD principles for successful drug approval, includes:

  • Developing PK/PD strategy as part of the drug development plan
  • Designing PK studies and sub-studies
  • Exposure-response modelling
  • PK and PK/PD analysis
  • Sparse sampling analysis
  • Bioequivalence analysis (individual and population)
  • In Vitro-In Vivo Correlation (IVIVC)
  • PK/PD modeling and simulation
  • Clinical trial simulation
  • Preparation of stand-alone or integrated summary reports
  • Preparing and producing pharmacokinetic and clinical pharmacology reports for all regulatory submissions

To learn more or to speak with an expert, contact us today.

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