Quality-by-design in pharmaceutical development: From current perspectives to practical applications

Current pharmaceutical research directions tend to follow a systematic approach in the field of applied research and development. The concept of quality-by-design (QbD) has been the focus of the current progress of pharmaceutical sciences. It is based on, but not limited, to risk assessment, design of experiments and other computational methods and process analytical technology. These tools offer a well-organized methodology, both to identify and analyse the hazards that should be handled as critical, and are therefore applicable in the control strategy. Once implemented, the QbD approach will augment the comprehension of experts concerning the developed analytical technique or manufacturing process. The main activities are oriented towards the identification of the quality target product profiles, along with the critical quality attributes, the risk management of these and their analysis through in silico aided methods. This review aims to offer an overview of the current standpoints and general applications of QbD methods in pharmaceutical development.

Automated summary

Current pharmaceutical research tends to follow a systematic approach in applied research and development, with a focus on quality-by-design (QbD) concept. QbD is based on risk assessment, design of experiments, and other computational methods, offering a well-organized methodology to identify and analyze critical hazards in the control strategy.