PK/PD Modeling & Simulation
PK/PD Strategies that Accelerate your Path to Approval—with the Data to Back it Up
Our Pharmacokinetics and Pharmacodynamics (PK/PD) modeling and simulation services can reduce uncertainty, improve efficiency, and provide a scientific foundation for regulatory decisions—helping Sponsors get safe, effective drugs to market faster.
Comprehensive PK/PD Solutions—On Your Terms
Our PK/PD modeling and simulation services can be tailored as standalone PK/PD services only or fully integrated PK/PD services with biostatistics.
Comprehensive PK/PD Services—Flexible, Scalable, and Aligned to Your Program
We offer a full suite of PK/PD services designed to support every stage of development, from early-phase planning through regulatory submission. Whether you’re conducting a single study or building a complete program, our team brings the experience and flexibility to tailor solutions that fit your compound and development goals.
Study Design & Planning
- Single- and multiple-dose PK studies
- Bioavailability & bioequivalence (BA/BE) studies
- Dose proportionality
- Drug-drug and drug-disease interaction studies
- Sparse sampling and population PK designs
Analysis & Modeling
- PK and PK/PD analysis
- Sparse sampling analysis
- BA/BE data analysis
- Toxicokinetics
- Population PK analysis
- PK/PD modeling and simulation
Strategic Documentation
- PK/PD analysis plan development
- Comprehensive report writing for regulatory submission
Smarter PK/PD Strategy
Powered by Summit Analytical
Our suite of PK/PD and biostatistical services are provided through Summit Analytical—a division of Lotus Clinical Research. Scientific rigor and regulatory insight drive successful drug development across pharmaceuticals, biotechnology, devices, and nutraceuticals.
