Results 1 to 10 of about 62,955,482 (158)
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 +4 more
exaly +7 more sources
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 ...
Réka Szoleczky +6 more
exaly +10 more sources
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 +6 more
openaire +4 more sources
Future Journal of Pharmaceutical SciencesAbstract Background Quality by design (QbD) adverts toward gaining of few expected quality with predetermined and desired specifications. Analytical quality by design (AQbD) approach toward the development of analytical method can significantly lead toward the rugged and robust method specially the assessment and risk
Sharib Raza Khan +3 more
openaire +3 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 +5 more
openaire +3 more sources
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 +3 more
wiley +1 more source
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 +11 more
wiley +1 more source
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 +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 +4 more
openaire +2 more sources
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 +6 more
wiley +1 more source