Pharmacometrics uses models to describe the beneficial and adverse effects of a drug therapy on a patient.
Data extracted from pre-clinical studies, clinical studies, scientific literature and competitor regulatory filings are integrated, building a complete data package describing the characteristics of a given lead compound.
From this integrated data set, mathematical models of exposure and response are built and qualified. These models become a representation of what is known about the compound's behavior.
By combining different types of models with a simulation step, a pharmacometrician brings quantitative insight to the strategic decisions arising in commercial drug development.
"The single-most important strength of pharmacometric analysis is its ability to integrate knowledge across the development program and compounds, and biology."
- U.S. FDA