Implementation of Analytical Quality by Design (AQbD) approach to RP-HPLC method for dissolution testing (CROSBI ID 713492)
Prilog sa skupa u zborniku | sažetak izlaganja sa skupa | međunarodna recenzija
Podaci o odgovornosti
Bartolec, Maja ; Pranjić, Josip ; Radošević, Senka ; Lusina Kregar, Maja
engleski
Implementation of Analytical Quality by Design (AQbD) approach to RP-HPLC method for dissolution testing
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.
quality by design ; method development ; dissolution
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Podaci o prilogu
54-54.
2015.
objavljeno
Podaci o matičnoj publikaciji
Fourth World Conference on Physico-Chemical Methods in Drug Discovery and Development, Programme & Book of Abstracts
Mandić, Zoran
International Association of Physical Chemists (IAPC)
Podaci o skupu
4th World Conference on Physico Chemical Methods in Drug Discovery and Development
poster
21.09.2015-24.09.2015
Rovinj, Hrvatska