Prikaz osnovnih podataka o dokumentu
Quality-by-design in pharmaceutical development
dc.creator | Đuriš, Jelena | |
dc.creator | Ibrić, Svetlana | |
dc.creator | Đurić, Zorica | |
dc.date.accessioned | 2019-09-02T11:37:23Z | |
dc.date.available | 2019-09-02T11:37:23Z | |
dc.date.issued | 2013 | |
dc.identifier.uri | https://farfar.pharmacy.bg.ac.rs/handle/123456789/2034 | |
dc.description.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. | en |
dc.publisher | Elsevier Inc. | |
dc.rights | restrictedAccess | |
dc.source | Computer-Aided Applications in Pharmaceutical Technology | |
dc.subject | Control strategies | en |
dc.subject | Design space | en |
dc.subject | Quality-by-design (QbD) | en |
dc.subject | Risk management tools | en |
dc.title | Quality-by-design in pharmaceutical development | en |
dc.type | bookPart | |
dc.rights.license | ARR | |
dcterms.abstract | Ибрић, Светлана; Ђурић, Зорица; Ђуриш, Јелена; | |
dc.citation.spage | 1 | |
dc.citation.epage | 16 | |
dc.citation.other | : 1-16 | |
dc.identifier.doi | 10.1016/B978-1-907568-27-5.50001-9 | |
dc.identifier.scopus | 2-s2.0-84904139815 | |
dc.type.version | publishedVersion |