Advanced Process Decision Making Using Multivariate Latent Variable Methods

This chapter is intended to show how latent variable modeling techniques can be used to support several pharmaceutical development and manufacturing activities by exploitation of historical databases deriving from experiments, ongoing manufacturing processes or historical products already developed. Basic theoretical concepts about latent variable modeling and latent variable model inversion are first introduced. Then, some applications are reviewed to show how the pharmaceutical industry can benefit from these modeling techniques to support decision-making activities in process development, formulation design, process scale-up, product transfer, process control, and raw materials acceptability assessment.