Results 31 to 40 of about 459 (187)

Using enhanced development tools offered by analytical Quality by Design to support switching of an analytical quality control method [PDF]

, 2023
Quality by Design (QbD) principles play an increasingly important role in pharmaceutical industry. Here, we used an analytical QbD (AQbD) approach to develop a capillary electrophoresis method under reducing conditions (rCE-SDS), with the aim of ...
Gritsch, Manuela, Kirsch, Stephan, Deissler, Michael, Anderka, Oliver, Pohl, Thomas, Bienert, Roland, Nerkamp, Joerg, Christoph, Roesli, Simeoni, Philippe   +8 more
core   +1 more source

Quality by Design‐Based Development of a Robust LC Method for Simultaneous Estimation of Process‐ and Degradation‐Related Impurities in Rifapentine Drug Product for the Treatment of Active and Latent Tuberculosis [PDF]

Biomed Chromatogr
ABSTRACT A precise, robust, and stability‐indicating liquid chromatographic (LC) method coupled with a photodiode array (PDA) detector was developed and validated for the quantitative estimation of rifapentine, an essential therapeutic agent for both active and latent tuberculosis (TB).
Korikana S, Battula S, Konduru N, Kurnool A, Vemuri D, Dantinapalli V.   +5 more
europepmc   +2 more sources

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

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

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

A state of the art in analytical quality-by-design and perspectives in characterization of nano-enabled medicinal products [PDF]

, 2022
International audienceQuality-by-Design (QbD) guidance is a risk-based and proactive approach to drug development proposed in the mid 2000s and now widely used in the pharmaceutical field in compliance with the ICH Q8-Q11 guidelines.
Borgos, Sven, Bastogne, Thierry, Prina-Mello, Adriele, Barberi-Heyob, Muriel, Caputo, Fanny   +4 more
core   +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

Sixteen capillary electrophoresis applications for viral vaccine analysis

ELECTROPHORESIS, Volume 43, Issue 9-10, Page 1068-1090, May 2022., 2022
Abstract A broad range of CE applications from our organization is reviewed to give a flavor of the use of CE within the field of vaccine analyses. Applicability of CE for viral vaccine characterization, and release and stability testing of seasonal influenza virosomal vaccines, universal subunit influenza vaccines, Sabin inactivated polio vaccines ...
Lars Geurink, Ewoud van Tricht, Debbie van der Burg, Gerard Scheppink, Bojana Pajic, Justin Dudink, Cari Sänger–van de Griend   +6 more
wiley   +1 more source