Preclinical/Phase I
ICON Development Solutions provides strategy and management in support of non-clinical drug development for all Phases.
PK/PD Modeling and Simulation
Pharmaceutical data analysis and methodology are critical factors in the drug approval process. ICON Development Solutions provides a comprehensive range of pharmacokinetic and pharmacodynamic modeling and simulation that are available either as individual components or as part of an integrated package.
ICON Development Solutions’ expertise in the application and presentation of pharmacokinetic (PK) and pharmacodynamic (PD) principles for successful drug approval including:
- Developing PK/PD strategy as part of the drug development plan
- Designing PK studies and sub-studies
- Performing efficient and quality analysis of experimental data including:
- Sample size and power calculations
- Generation of randomised code
- Preparation of analysis plans
- PK and PK/PD analysis
- Sparse sampling analysis
- Bioequivalence analysis (individual and population)
- Toxicokinetics
- In Vitro-In Vivo Correlation (IVIVC)
- Bayesian forecasting
- PK/PD modeling and simulation
- Clinical trial simulation
- Disease State modeling
- Tabulation, graphical display, analysis and interpretation of study data
- Preparation of stand-alone or integrated summary reports
- Preparing and producing pharmacokinetic and clinical pharmacology reports for all regulatory submissions
- Meeting with regulatory agencies with or on behalf of clients