- What is the extent of exposure to our drug?
- Is it getting to the action site and in the right amount?
- What is the impact of between-patient variability? How large is it?
- Do we need to reformulate?
- Is there a gender difference? Is exposure different in Asia/Africa/Europe?
- What is the best dose and schedule?
qPharmetra has the Know-How to Address these Problems
At the core of almost every Pharmacometric project is a characterization of drug exposure whether by classical pharmacokinetic (PK) or population pharmacokinetic (PopPK) analysis. Broadly, this involves anything from simple non-compartmental (NCA) modeling to non-linear mixed effects modeling to characterize the time-course and variability in drug exposure. It also often involves a systematic review of alternative structural models and the effects of patient demographic covariates.
qPharmetra has invested in systematizing their approach to population PK analysis. We have standardized our work processes from initial project preparation through final documentation, automating the portions that maximize efficiency and quality review.
Your Result: Robust Results and Clear, Consistent Reports
This means our clients can have confidence that the data were prepared properly, models meet current standards for acceptability, simulations produce credible results, and the final analysis document will be a professional and thorough record of the results. Our Regulatory-ready formal reports codify the search for and findings of the best model.