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.
Ključne reči:
Control strategies / Design space / Quality-by-design (QbD) / Risk management tools
Izvor:
Computer-Aided Applications in Pharmaceutical Technology, 2013, 1-16
TY - CHAP
AU - Đuriš, Jelena
AU - Ibrić, Svetlana
AU - Đurić, Zorica
PY - 2013
UR - http://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 -
@article{
author = "Đuriš, Jelena and Ibrić, Svetlana and Đurić, Zorica",
year = "2013",
url = "http://farfar.pharmacy.bg.ac.rs/handle/123456789/2034",
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",
title = "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. Quality-by-design in pharmaceutical development. Computer-Aided Applications in Pharmaceutical Technology. 2013;:1-16
Đuriš, J., Ibrić, S.,& Đurić, Z. (2013). Quality-by-design in pharmaceutical development.
Computer-Aided Applications in Pharmaceutical TechnologyElsevier Inc.., 1-16.
https://doi.org/10.1016/B978-1-907568-27-5.50001-9
