Pregledni rad

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

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

BÉLA KOVÁCS orcid.org/0000-0003-3881-8636 ; Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Târgu Mureș, 540142 Târgu Mures, Romania
BOGLÁRKA KOVÁCS-DEÁK ; Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Târgu Mureș, 540142 Târgu Mures, Romania
ISTVÁN SZÉKELY-SZENTMIKLÓSI ; Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Târgu Mureș, 540142 Târgu Mures, Romania
IBOLYA FÜLÖP orcid.org/0000-0003-3973-3458 ; Department F2, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Târgu, 540142 Târgu Mures, Romania
LÁSZLÓ-ISTVÁN BÁBA ; Department F2, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Târgu, 540142 Târgu Mures, Romania
FRANCISC BODA orcid.org/0000-0003-3777-3712 ; Department F1, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Târgu Mureș, 540142 Târgu Mures, Romania
ORSOLYA PÉTERFI orcid.org/0000-0002-1921-1452 ; Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Târgu Mureș, 540142 Târgu Mures, Romania

Sažetak

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.

Ključne riječi

quality-by-design; pharmaceutical development; risk assessment; software-aided development

Hrčak ID:

246699

URI

https://hrcak.srce.hr/246699

Datum izdavanja:

31.12.2021.

Posjeta: 2.675 *