Results 21 to 30 of about 279 (161)

Rheology of Complex Topical Formulations: An Analytical Quality by Design Approach to Method Optimization and Validation

Pharmaceutics, 2023
Analytical method validation ensures that a method provides trustworthy information about a particular sample when applied in accordance with the predefined protocol. According to regulatory standards, the rheological characteristics of topically applied
Lucas Chiarentin, Catarina Cardoso, Margarida Miranda, Carla Vitorino   +3 more
doaj   +1 more source

Perspectives in modeling and model validation during analytical quality by design chromatographic method evaluation: a case study

AAPS Open, 2021
Design of experiments (DOE)-based analytical quality by design (AQbD) method evaluation, development, and validation is gaining momentum and has the potential to create robust chromatographic methods through deeper understanding and control of ...
Yongzhi Dong, Zhimin Liu, Charles Li, Emily Pinter, Alan Potts, Tanya Tadey, William Weiser   +6 more
doaj   +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

Green RP-UPLC Method for Simultaneous Determination of Cyclopentolate and Organic Impurities Using DoE and Sustainability Metrics. [PDF]

Int J Anal Chem
A significant improvement in sustainability and efficiency is achievable through green and white chemistry. As part of this study, sustainability assessment tools were used to assess the environmental impact and practicality of an innovative, straightforward RP‐UPLC method to analyze cyclopentolate (CLO) and its organic impurities simultaneously in ...
Alsehli BR, Alluhayb AH, Al-Khateeb LA, Saleh SM, Binsaleh AY, Mohamed MA.   +5 more
europepmc   +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

Quality by design‐guided development of a capillary electrophoresis method for the simultaneous chiral purity determination and impurity profiling of tamsulosin

Journal of Separation Science, Volume 46, Issue 24, December 2023., 2023
Analytical Quality by Design principles using the design of experiments were applied for the development of a capillary electrophoresis method for the determination of enantiomeric purity and chemically related impurities of tamsulosin. From initial scouting experiments, a dual cyclodextrin (CD) system composed of sulfated β‐CD and carboxymethyl‐α‐CD ...
Adriana Modroiu, Sulaiman Krait, Gabriel Hancu, Gerhard K. E. Scriba   +3 more
wiley   +1 more source

Expediting Disulfiram Assays through a Systematic Analytical Quality by Design Approach

Chemosensors, 2021
An Analytical Quality by Design (AQbD) approach is presented, aiming at the development and validation of an HPLC method for the quantification of disulfiram and copper diethyldithiocarbamate in lipid nanoparticles.
João Basso, Maria Luísa Ramos, Alberto Pais, Rui Vitorino, Ana Fortuna, Carla Vitorino   +5 more
doaj   +1 more source

Strategies for capillary electrophoresis: Method development and validation for pharmaceutical and biological applications—Updated and completely revised edition

ELECTROPHORESIS, Volume 44, Issue 17-18, Page 1279-1341, September 2023., 2023
Abstract This review is in support of the development of selective, precise, fast, and validated capillary electrophoresis (CE) methods. It follows up a similar article from 1998, Wätzig H, Degenhardt M, Kunkel A. “Strategies for capillary electrophoresis: method development and validation for pharmaceutical and biological applications,” pointing out ...
Finja Krebs, Holger Zagst, Matthias Stein, Ratih Ratih, Robert Minkner, Mais Olabi, Sophie Hartung, Christin Scheller, Blanca H. Lapizco‐Encinas, Cari Sänger‐van de Griend, Carlos D. García, Hermann Wätzig   +11 more
wiley   +1 more source

Quality by Design (QbD) Based Method for Estimation of Xanthohumol in Bulk and Solid Lipid Nanoparticles and Validation

Molecules, 2023
The analytical quality by design (AQbD) approach is utilized for developing and validating the simple, sensitive, cost-effective reverse-phase high performance liquid chromatographic method for the estimation of xanthohumol (XH) in bulk and ...
Vancha Harish, Waleed Hassan Almalki, Ahmed Alshehri, Abdulaziz Alzahrani, Madan Mohan Gupta, Sami I. Alzarea, Imran Kazmi, Monica Gulati, Devesh Tewari, Gaurav Gupta, Kamal Dua, Sachin Kumar Singh   +11 more
doaj   +1 more source

Process analytical technique (PAT) miniaturization for monoclonal antibody aggregate detection in continuous downstream processing

Journal of Chemical Technology &Biotechnology, Volume 97, Issue 9, Page 2347-2364, September 2022., 2022
Abstract The transition to continuous biomanufacturing is considered the next step to reduce costs and improve process robustness in the biopharmaceutical industry, while also improving productivity and product quality. The platform production process for monoclonal antibodies (mAbs) is eligible for continuous processing to lower manufacturing costs ...
Mariana N São Pedro, Marieke E Klijn, Michel HM Eppink, Marcel Ottens   +3 more
wiley   +1 more source