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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

Bartolec, Maja ; Pranjić, Josip ; Radošević, Senka ; Lusina Kregar, Maja 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.). International Association of Physical Chemists (IAPC), 2015. str. 54-54

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

Povezanost rada

Farmacija

Poveznice