PRODUCT DEVELOPMENT SERVICES
Pharmacokinetic/Pharmacodynamics

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