9Experiments Involving Formulation and Process Variables
“Design Space - The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality”.
International Commission on Harmony for Pharmaceutical Industry Q8 (ICH 2015)
Overview
We have provided strategies, methods, and tools for experimenting with formulations. However, in many applications, there are process variables that affect the formulation and may in fact interact with the components. For example, the best baking time and temperature for bread may depend on the ingredient mix. In this chapter we provide strategies for development of formulation systems involving process variables, ...
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