United States Pharmacopeia

Proposed Project for the MSU Industrial Math Students

A Risk-Based Approach to Pharmaceutical Quality Control – Extended Mathematical Modeling

This project will build off of an existing collaboration between MSU and the United States Pharmacopeia. The project will look at expanding and improving a mathematical-based predictive model that provides information on the likelihood or risk that a given pharmaceutical is of poor quality and hence whether it should be prioritized for full compendial testing or not.

The current model includes factors that determine whether a given product will fail quality control based on historical data. Additional risk factors will be included in the improved model to determine the overall risk of not conducting full compendial test of a given medicine based on non QC-related factors such a therapeutic window, extent of mass distribution, etc. All of these factors will be modeled together with the QC-related factors to determine the risk to patient of not conducting full compendial testing.