Aims and Objectives and of Experimental Design and Optimization in Formulation and Process Development

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).