Pregled bibliografske jedinice broj: 1171917
Implementation of Analytical Quality by Design (AQbD) approach to RP-HPLC method for dissolution testing
Implementation of Analytical Quality by Design (AQbD) approach to RP-HPLC method for dissolution testing // Fourth World Conference on Physico-Chemical Methods in Drug Discovery and Development, Programme & Book of Abstracts / Mandić, Zoran (ur.).
Rovinj, Hrvatska: International Association of Physical Chemists (IAPC), 2015. str. 54-54 (poster, međunarodna recenzija, sažetak, znanstveni)
CROSBI ID: 1171917 Za ispravke kontaktirajte CROSBI podršku putem web obrasca
Naslov
Implementation of Analytical Quality by Design (AQbD)
approach to RP-HPLC method for dissolution testing
Autori
Bartolec, Maja ; Pranjić, Josip ; Radošević, Senka ; Lusina Kregar, Maja
Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, znanstveni
Izvornik
Fourth World Conference on Physico-Chemical Methods in Drug Discovery and Development, Programme & Book of Abstracts
/ Mandić, Zoran - : International Association of Physical Chemists (IAPC), 2015, 54-54
Skup
4th World Conference on Physico Chemical Methods in Drug Discovery and Development
Mjesto i datum
Rovinj, Hrvatska, 21.09.2015. - 24.09.2015
Vrsta sudjelovanja
Poster
Vrsta recenzije
Međunarodna recenzija
Ključne riječi
quality by design ; method development ; dissolution
Sažetak
Quality by Design (QbD) principles were implemented in RP-HPLC method development for the analysis of dissolution samples of immediate release film-coated tablets. Critical method variables and critical method attributes were identified. After the initial risk assessment, a DoE (design of experiments) study was performed to investigate the impact of potentially critical method variables on critical method attributes. Based on the DoE study results, updated risk assessment was prepared.
Izvorni jezik
Engleski
Znanstvena područja
Farmacija
POVEZANOST RADA
Ustanove:
PLIVA HRVATSKA d.o.o.
