In silico methods have been identified as part of the solution to more efficient drug-development programs.
The Data Management and Biometrics team performs population PK/PD analysis with animal and human data, from Celerion sites and external partners. Data are analyzed using NONMEM®, ADAPT-5®, SAS® and R®. Population PK/PD modeling and simulation allow for cost and time savings compared with running additional clinical studies to obtain information needed to move forward with clinical development.
Once a model is established with all key elements, simulations can be made, allowing for selection of future dosing regimens and optimal sampling strategies. This enables efficient, cost-effective and scientifically sound study designs that help get your drugs to market faster.
Comprehensive modeling and simulation services:
- Population PK/PD modeling and simulation
- Development of programs from preclinical to First-in-Human PK for NDA submission
- Guidance for future studies by optimizing study designs regarding dose selection, population selection, sampling schedule, drug-drug interactions, etc.