Results 1 to 10 of about 529 (166)

Analytical Quality by Design (AQbD) Approach to the Development of In Vitro Release Test for Topical Hydrogel [PDF]

Pharmaceutics, 2022
The aim of our study was to adapt the analytical quality by design (AQbD) approach to design an effective in vitro release test method using USP apparatus IV with a semi-solid adapter (SSA) for diclofenac sodium hydrogel. The analytical target profile (ATP) of the in vitro release test and ultra-high-performance liquid chromatography were defined; the ...
Berkó Szilvia, Budai-Szűcs Mária, Csányi Erzsébet, Kovács Anita, Pannonhalminé Csóka Ildikó, Szoleczky Réka, Tonka-Nagy Péter   +6 more
core   +10 more sources

Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants [PDF]

Plants, 2022
Scientific regulatory systems with suitable analytical methods for monitoring quality, safety, and efficacy are essential in medicinal plant drug discovery. There have been only few attempts to adopt the analytical quality by design (AQbD) strategy in medicinal plants analysis over the last few years.
Geonha Park, Min Kyoung Kim, Seung Hyeon Go, Minsik Choi, Young Pyo Jang   +4 more
openaire   +4 more sources

Analytical Quality by Design-Compliant Development of a Cyclodextrin-Modified Micellar ElectroKinetic Chromatography Method for the Determination of Trimecaine and Its Impurities [PDF]

Molecules, 2023
In 2022, the International Council for Harmonisation released draft guidelines Q2(R2) and Q14, intending to specify the development and validation activities that should be carried out during the lifespan of an analytical technique addressed to assess ...
Dousa M., Furlanetto S., Gotti R., Jires J., Marzullo L., Nekvapilova P., Orlandini S., Rezanka P., Slavickova P., Zapadlo M.   +9 more
core   +5 more sources

Systematic Development and Validation of a Thin-Layer Densitometric Bioanalytical Method for Estimation of Mangiferin Employing Analytical Quality by Design (AQbD) Approach [PDF]

Journal of Chromatographic Science, 2016
The present work aims at the systematic development of a simple, rapid and highly sensitive densitometry-based thin-layer chromatographic method for the quantification of mangiferin in bioanalytical samples. Initially, the quality target method profile was defined and critical analytical attributes (CAAs) earmarked, namely, retardation factor (Rf ...
Rajneet Kaur, Khurana, Satish, Rao, Sarwar, Beg, O P, Katare, Bhupinder, Singh   +4 more
openaire   +3 more sources

New Trends in the Quality Control of Enantiomeric Drugs: Quality by Design-Compliant Development of Chiral Capillary Electrophoresis Methods [PDF]

Molecules, 2022
Capillary electrophoresis (CE) is a potent method for analyzing chiral substances and is commonly used in the enantioseparation and chiral purity control of pharmaceuticals from different matrices.
Furlanetto S., Gotti R., Hancu G., Modroiu A., Orlandini S., Papp L. -A., Szabo Z. -I.   +6 more
core   +2 more sources

An analytical quality by design (aQbD) approach for a l -asparaginase activity method [PDF]

Journal of Pharmaceutical and Biomedical Analysis, 2016
L-asparaginase is an effective anti-tumor agent for acute lymphoblastic leukemia. This work presents the development of an activity determination of L-ASNase preparations for pharmaceutical quality control purposes, in accordance with analytical Quality by Design principles.
Han Yao, Jochem Vancoillie, Matthias D’Hondt, Evelien Wynendaele, Nathalie Bracke, Bart De Spiegeleer   +5 more
openaire   +3 more sources

Development and Validation of an In‐Line API Quantification Method Using AQbD Principles Based on UV‐Vis Spectroscopy to Monitor and Optimise Continuous Hot Melt Extrusion Process [PDF]

, 2020
open access journalA key principle of developing a new medicine is that quality should be built in, with a thorough understanding of the product and the manufacturing process supported by appropriate process controls.
Almeida, Juan, Berghaus, Andreas, Bezerra, Mariana, Borman, Phil, Markl, Daniel, Schlindwein, W. S.   +5 more
core   +2 more sources

Application of quality-by-design approach in the analytical method development for quantification of sugars in sugarcane honey by reversed-phase liquid chromatography [PDF]

, 2020
Produced in Madeira Island from regional sugarcane cultivars through a traditional manufacturing and storage process, sugarcane honey (SCH) is a black syrup recognized by its excellent quality.
Câmara, José S., Nunes, Fernando M., Perestrelo, Rosa, Silva, Catarina L., Silva, Pedro   +4 more
core   +1 more source

Analytical Lifecycle Management (ALM) and Analytical Quality by Design (AQbD) for analytical procedure development of related substances in tenofovir alafenamide fumarate tablets

Journal of Pharmaceutical and Biomedical Analysis, 2022
Analytical procedure development for quantifying 10 impurities in Tenofovir Alafenamide Fumarate (TAF) tablets was a challenge for analytical and formulation researchers. The aim of this paper was to develop a robust, regulatory-flexible, application-specific Ultra Performance Liquid Chromatography (UPLC) analytical procedure using the Analytical ...
Jianhao, Teng, Chunmei, Zhu, Jinyuan, Lyu, Linyu, Pan, Meng, Zhang, Fuli, Zhang, Haoxiang, Wu   +6 more
openaire   +2 more sources

Integrated Analytical Quality by Design (AQbD) Approach for the Development and Validation of Bioanalytical Liquid Chromatography Method for Estimation of Valsartan [PDF]

Journal of Chromatographic Science, 2020
Abstract The present studies describe the systematic development and validation of a simple, rapid, sensitive and cost-effective reversed-phase high-performance liquid chromatographic bioanalytical method for the estimation of valsartan in rat plasma employing analytical quality by design (AQbD) principles quality risk management was ...
Shantanu, Bandopadhyay, Sarwar, Beg, O P, Katare, Teenu, Sharma, Bhupinder, Singh   +4 more
openaire   +2 more sources