Pharmaceutical data analysis and methodology are critical factors in the drug
approval process. ICON Development Solutions provides a comprehensive range of
pharmacokinetic and report writing services that are available either as individual
components or as part of an integrated package.
ICON Development Solutions industry-recognized expertise in the application and
presentation of pharmacokinetic (PK) and pharmacodynamic (PD) principles for
successful drug approval includes:
Developing PK/Biopharmaceuticals strategy as part of the drug
development plan
Designing PK studies and substudies
Performing efficient and quality analysis of experimental data including:
PK and PK/PD Analysis
In Vitro-In Vivo Correlation (IVIVC)
Clinical Trial Simulation
Bioequivalence Analysis (Individual and Population)
Bayesian Forecasting
Sparse Sampling Analysis
Analysis of Pediatric PK and PK/PD Data
Toxicokinetics
Simulation
PK/PD Modeling
Sample Size and Power Calculations
Generation of Randomized Code
Preparation of Analysis Plans
Tabulation, graphical display, analysis and interpretation of study data
Preparing and producing pharmacokinetic and clinical pharmacology reports for all regulatory
submissions
Meeting with regulatory agencies with or on behalf of clients
