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...
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| Format: | Article |
| Language: | English |
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Sciendo
2021-12-01
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| Series: | Acta Pharmaceutica |
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| Online Access: | https://doi.org/10.2478/acph-2021-0039 |
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| author | Kovács Béla Péterfi Orsolya Kovács-Deák Boglárka Székely-Szentmiklósi István Fülöp Ibolya Bába László-István Boda Francisc |
| author_facet | Kovács Béla Péterfi Orsolya Kovács-Deák Boglárka Székely-Szentmiklósi István Fülöp Ibolya Bába László-István Boda Francisc |
| author_sort | Kovács Béla |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-7e92fb976f3c441e9e234d06aa509c88 |
| institution | Kabale University |
| issn | 1846-9558 |
| language | English |
| publishDate | 2021-12-01 |
| publisher | Sciendo |
| record_format | Article |
| series | Acta Pharmaceutica |
| spelling | doaj-art-7e92fb976f3c441e9e234d06aa509c882025-02-02T16:56:11ZengSciendoActa Pharmaceutica1846-95582021-12-0171449752610.2478/acph-2021-0039Quality-by-design in pharmaceutical development: From current perspectives to practical applicationsKovács Béla0Péterfi Orsolya1Kovács-Deák Boglárka2Székely-Szentmiklósi István3Fülöp Ibolya4Bába László-István5Boda Francisc6Department F1, Faculty of Pharmacy, George Emil Palade University of Medicine Pharmacy, Science, and Technology of Târgu Mureș, 540142Târgu Mures, RomaniaFaculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy Science, and Technology of Târgu Mureș540142Târgu Mures, RomaniaFaculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy Science, and Technology of Târgu Mureș540142Târgu Mures, RomaniaFaculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy Science, and Technology of Târgu Mureș540142Târgu Mures, RomaniaDepartment F2, Faculty of Pharmacy, George Emil Palade University of Medicine Pharmacy, Science, and Technology of Târgu, 540142Târgu Mures, RomaniaDepartment F2, Faculty of Pharmacy, George Emil Palade University of Medicine Pharmacy, Science, and Technology of Târgu, 540142Târgu Mures, RomaniaDepartment F1, Faculty of Pharmacy, George Emil Palade University of Medicine Pharmacy, Science, and Technology of Târgu Mureș, 540142Târgu Mures, RomaniaCurrent 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.https://doi.org/10.2478/acph-2021-0039quality-by-designpharmaceutical developmentrisk assessmentsoftware-aided development |
| spellingShingle | Kovács Béla Péterfi Orsolya Kovács-Deák Boglárka Székely-Szentmiklósi István Fülöp Ibolya Bába László-István Boda Francisc Quality-by-design in pharmaceutical development: From current perspectives to practical applications Acta Pharmaceutica quality-by-design pharmaceutical development risk assessment software-aided development |
| title | Quality-by-design in pharmaceutical development: From current perspectives to practical applications |
| title_full | Quality-by-design in pharmaceutical development: From current perspectives to practical applications |
| title_fullStr | Quality-by-design in pharmaceutical development: From current perspectives to practical applications |
| title_full_unstemmed | Quality-by-design in pharmaceutical development: From current perspectives to practical applications |
| title_short | Quality-by-design in pharmaceutical development: From current perspectives to practical applications |
| title_sort | quality by design in pharmaceutical development from current perspectives to practical applications |
| topic | quality-by-design pharmaceutical development risk assessment software-aided development |
| url | https://doi.org/10.2478/acph-2021-0039 |
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