FarFaR - Farmaceutski fakultet, repozitorijum
Univerzitet u Beogradu, Farmaceutski fakultet
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  •   FarFaR - Farmaceutski fakultet, repozitorijum
  • Pharmacy
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  •   FarFaR - Farmaceutski fakultet, repozitorijum
  • Pharmacy
  • Radovi istraživača / Researchers’ publications
  • Pregled rada
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Quality-by-design in pharmaceutical development

Samo za registrovane korisnike
2013
Autori
Đuriš, Jelena
Ibrić, Svetlana
Đurić, Zorica
Poglavlje u monografiji (Objavljena verzija)
Metapodaci
Prikaz svih podataka o dokumentu
Apstrakt
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
Izdavač:
  • 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
Kolekcije
  • Radovi istraživača / Researchers’ publications
Institucija
Pharmacy

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