FarFaR - Pharmacy Repository
University of Belgrade, Faculty of Pharmacy
    • English
    • Српски
    • Српски (Serbia)
  • English 
    • English
    • Serbian (Cyrilic)
    • Serbian (Latin)
  • Login
View Item 
  •   FarFaR
  • Pharmacy
  • Radovi istraživača / Researchers’ publications
  • View Item
  •   FarFaR
  • Pharmacy
  • Radovi istraživača / Researchers’ publications
  • View Item
JavaScript is disabled for your browser. Some features of this site may not work without it.

Quality-by-design in pharmaceutical development

Authorized Users Only
2013
Authors
Đuriš, Jelena
Ibrić, Svetlana
Đurić, Zorica
Book part (Published version)
Metadata
Show full item record
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.
Keywords:
Control strategies / Design space / Quality-by-design (QbD) / Risk management tools
Source:
Computer-Aided Applications in Pharmaceutical Technology, 2013, 1-16
Publisher:
  • Elsevier Inc.

DOI: 10.1016/B978-1-907568-27-5.50001-9

Scopus: 2-s2.0-84904139815
[ Google Scholar ]
2
URI
http://farfar.pharmacy.bg.ac.rs/handle/123456789/2034
Collections
  • Radovi istraživača / Researchers’ publications
Institution
Pharmacy

DSpace software copyright © 2002-2015  DuraSpace
About FarFaR - Pharmacy Repository | Send Feedback

OpenAIRERCUB
 

 

All of DSpaceInstitutionsAuthorsTitlesSubjectsThis institutionAuthorsTitlesSubjects

Statistics

View Usage Statistics

DSpace software copyright © 2002-2015  DuraSpace
About FarFaR - Pharmacy Repository | Send Feedback

OpenAIRERCUB