We Offer:
- Population (nonlinear mixed-effects) pharmacokinetic (PK) and pharmacodynamic (PK-PD) modeling and clinical trial simulation to support drug development programs;
- Population PK and PK-PD data analyses, including preparation of FDA submission-ready reports;
- Pharmacokinetic design and analysis of pediatric studies;
- Population PK-PD analysis of continuous or categorical responses, count data, survival, time-to-event, or QTc prolongation data;
- In vivo - in vitro correlation (IVIVC) analysis;
- On-demand support of sponsor's modeling efforts, including data management, NONMEM®, S-plus and R script development;
- Critical review of population PK and PK-PD analyses;
- Presentation at conferences and meetings;
- Preparation of publications;
- Fast turn-around time and complete transfer of know-how related to the sponsor's projects.
Strict confidentiality, scientific expertise and integrity, high efficiency and close collaboration with the sponsor form the foundation of our services.