ICON offers expert clinical and nonclinical pharmacokinetic, pharmacodynamic, and exposure response data analysis services.
Non-compartmental (NCA) and model‑based (i.e. population) PK, PD, and ER analyses are performed by trained pharmacokineticists and pharmacometricians using industry-leading software (Phoenix WinNonlin® and NONMEM®/R). We plan, design, monitor, execute, analyze, and interpret your individual clinical or nonclinical PK studies.
Our services include:
- Strategic consulting
- Model development
- Simulation to support Model Informed Drug Development and Discovery (MID3)
As your partner, we work with you to design MID3 strategies to leverage available data from multiple studies to provide timely, evidence‑based support for internal decision making and regulatory filings.
Our experience affords a range of capabilities:
- Exposure-based target selection and lead optimization
- Nonclinical PK (including toxicokinetics), PD, and ER using NCA and model‑based methods
- Allometry and model‑based prediction of human PK and dose selection First-In-Human studies.
- In Vitro/In Vivo correlation and deconvolution analyses to support formulation development
- Clinical PK, PD, and ER using NCA and model‑based methods
- PK and PK/PD study design
- Optimal PK and PD sample scheduling
- Population‑based PK, PD, and ER modeling and simulation
- Clinical trial simulation
- Fast turnaround of NCAs for dose-escalation and trial adaptation decisions
- Expert review of data
- Due diligence assessments
- Authoring of QP&PMx‑related sections of protocols, analysis plans, study reports, and regulatory documents
- Consultancy to support drug development and study design
Whether you are looking for consultancy, support for single studies, or contribution to programs of work, ICON’s QP&PMx specialists can help to advance your project and save you time and expense.