ABSTRACT

The main objective of product and process optimization is to ensure that the intended commercial product is robustly optimized to comply with the design specifi cations, key business requirements (KBRs), critical manufacturing attributes (CMAs), and critical quality attributes (CQAs) defined in the target product profile (TPP). This entry examines the construction and analysis of the different types of designs of experiments that are possible using commercially available and user-friendly software tools.