Quality-by-design in pharmaceutical development
Само за регистроване кориснике
2013
Поглавље у монографији (Објављена верзија)
Метаподаци
Приказ свих података о документуАпстракт
This first chapter introduces the concept of quality-by-design (QbD) and its role in pharmaceutical product development. QbD assures the quality of a pharmaceutical product through scientific development and risk management tools, and will eventually enable real-time release, regardless of the formulation type. Several guidelines on pharmaceutical development, quality risk management, and pharmaceutical quality systems are presented that are applicable throughout the product lifecycle. Design space appointment and control strategies for risk management are introduced. The meaning of the QbD concept is presented from both regulatory and manufacturers' points of view. Several illustrative examples are provided to facilitate the understanding of the QbD concept and ease of its application.
Кључне речи:
Control strategies / Design space / Quality-by-design (QbD) / Risk management toolsИзвор:
Computer-Aided Applications in Pharmaceutical Technology, 2013, 1-16Издавач:
- Elsevier Inc.
Институција/група
PharmacyTY - CHAP AU - Đuriš, Jelena AU - Ibrić, Svetlana AU - Đurić, Zorica PY - 2013 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2034 AB - This first chapter introduces the concept of quality-by-design (QbD) and its role in pharmaceutical product development. QbD assures the quality of a pharmaceutical product through scientific development and risk management tools, and will eventually enable real-time release, regardless of the formulation type. Several guidelines on pharmaceutical development, quality risk management, and pharmaceutical quality systems are presented that are applicable throughout the product lifecycle. Design space appointment and control strategies for risk management are introduced. The meaning of the QbD concept is presented from both regulatory and manufacturers' points of view. Several illustrative examples are provided to facilitate the understanding of the QbD concept and ease of its application. PB - Elsevier Inc. T2 - Computer-Aided Applications in Pharmaceutical Technology T1 - Quality-by-design in pharmaceutical development SP - 1 EP - 16 DO - 10.1016/B978-1-907568-27-5.50001-9 ER -
@inbook{ author = "Đuriš, Jelena and Ibrić, Svetlana and Đurić, Zorica", year = "2013", abstract = "This first chapter introduces the concept of quality-by-design (QbD) and its role in pharmaceutical product development. QbD assures the quality of a pharmaceutical product through scientific development and risk management tools, and will eventually enable real-time release, regardless of the formulation type. Several guidelines on pharmaceutical development, quality risk management, and pharmaceutical quality systems are presented that are applicable throughout the product lifecycle. Design space appointment and control strategies for risk management are introduced. The meaning of the QbD concept is presented from both regulatory and manufacturers' points of view. Several illustrative examples are provided to facilitate the understanding of the QbD concept and ease of its application.", publisher = "Elsevier Inc.", journal = "Computer-Aided Applications in Pharmaceutical Technology", booktitle = "Quality-by-design in pharmaceutical development", pages = "1-16", doi = "10.1016/B978-1-907568-27-5.50001-9" }
Đuriš, J., Ibrić, S.,& Đurić, Z.. (2013). Quality-by-design in pharmaceutical development. in Computer-Aided Applications in Pharmaceutical Technology Elsevier Inc.., 1-16. https://doi.org/10.1016/B978-1-907568-27-5.50001-9
Đuriš J, Ibrić S, Đurić Z. Quality-by-design in pharmaceutical development. in Computer-Aided Applications in Pharmaceutical Technology. 2013;:1-16. doi:10.1016/B978-1-907568-27-5.50001-9 .
Đuriš, Jelena, Ibrić, Svetlana, Đurić, Zorica, "Quality-by-design in pharmaceutical development" in Computer-Aided Applications in Pharmaceutical Technology (2013):1-16, https://doi.org/10.1016/B978-1-907568-27-5.50001-9 . .