Datasheet | February 13, 2012

PK/PD Modeling & Simulation Datasheet

Source: ICON

ICON Development Solutions has industry-recognized expertise in the application and presentation of pharmacokinetic (PK) and pharmacodynamic (PD) principles critical for successful drug approval, with experience over the past 5 years that includes the following:

  • Over 300 PK projects
  • 80 population PK and PK/PD analysis and reports
  • Vast experience in interactions with regulatory authorities on PK and biopharmaceutics results, leveraging staff member regulatory career experience and regular interactions on behalf of clients

Developing PK/Biopharmaceutics Strategy As Part Of The Drug Development Plan
ICON applies its scientific and regulatory expertise to developing over-arching PK/Biopharmaceutics strategy,and to designing individual PK studies and substudies to expedite the drug development process.

Performing Efficiency and Quality Analysis
ICON performs comprehensive support for pharmacokinetic analyses and reports, including:

  • PK and PK/PD Analysis
  • Population PK and PD Analysis
  • In Vitro-In Vivo Correlation (IVIVC)
  • Clinical Trial Simulation
  • Bioequivalence Analysis
  • Bayesian Forecasting
  • Sparse Sampling Analysis
  • Analysis of Podiatric PK and PK/PD Data
  • Toxicokinetics
  • Preparing pharmacokinetic and clinical pharmacology reports for all regulatory submissions

Analyses are performed and reports are written by senior level pharmacokineticists and peer-reviewed to ensure that they are regulatory-ready.