<abstract xmlns="http://www.w3.org/1999/xhtml"><p>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 <italic>in silico</italic> aided methods. This review aims to offer an overview of the current standpoints and general applications of QbD methods in pharmaceutical development.</p></abstract>

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.

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

George Emil Palade University of Medicine Pharmacy, Science, and Technology of Târgu Mureș

George Emil Palade University of Medicine, Pharmacy Science, and Technology of Târgu Mureș

George Emil Palade University of Medicine Pharmacy, Science, and Technology of Târgu

Acta Pharmaceutica

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Current pharmaceutical research directions tend to follow a systematic approach in the field of applied research and development. The concept of...

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

Publié en ligne: 03 avr. 2021

Pages: 497 - 526

Accepté: 23 nov. 2020

DOI: https://doi.org/10.2478/acph-2021-0039

Mots clés
quality-by-design, pharmaceutical development, risk assessment, software-aided development

© 2021 Béla Kovács et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

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

Publié en ligne: 03 avr. 2021

Pages: 497 - 526

Accepté: 23 nov. 2020

DOI: https://doi.org/10.2478/acph-2021-0039

Mots clésquality-by-design, pharmaceutical development, risk assessment, software-aided development

© 2021 Béla Kovács et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Mots clés
quality-by-design, pharmaceutical development, risk assessment, software-aided development