ABSTRACT
The use of the “Statistical Design of Experiments” (DOE) has a long history with roots
going back as far as the 1960s. While initially DOE was mainly used as a tool in academia
(1,2), the pharmaceutical industry quickly realized the potential of DOE and numerical
optimization based on mathematical models for a rapid, precise, and safe development of
formulations and processes, as well as scale up, validation and troubleshooting (3,4).