Design Space of Drug Product: Empirical Modelling Based on Multivariate Projection Methods

In this approach, the definition of design space is taken literally and Quality is expressed (in one model) as a function of the multidimensional combination of raw material ( API and excipients), parameters of the process (Granulation, Drying, Blending, Compression, Coating) and IPC's.

A multivariate structure is also maintained for quality.

Separate models provide support for control strategy in a feed forward mode. Multivariate projection methods are used for modelling, while scientific and other knowledge is incorporated to create hybrid models.

The structure of the multi- factor DOE's required to derive such a model is discussed, as well as ways to develop control strategy based on empirical data.