Results 21 to 30 of about 329 (162)

Discriminative Dissolution Method Development Through an aQbD Approach

AAPS PharmSciTech, 2023
AbstractUsing a one-factor-at-a-time approach for dissolution method and discrimination analysis can be time-consuming and may not yield the optimal and discriminative method. To address this, we have developed a two-stage workflow for the dissolution method development followed by demonstration of discrimination power through an analytical Quality by ...
Hongbo Chen, Rui Wang, John-David McElderry   +2 more
openaire   +2 more sources

Definições e escopo dos elementos-chave do Analytical Quality by Design (AQbD) para o desenvolvimento de métodos na indústria farmacêutica

Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia, 2023
Introdução: O setor farmacêutico está em constante evolução e é altamente regulado com normas para garantir eficácia, segurança e qualidade dos medicamentos.
Rosemberg Bernardez Moure, Flávia Furtado de Mendonça de Sousa, Diogo Dibo do Nascimento, Jorge Lima de Magalhães, Camila Areias de Oliveira, Livia Deris Prado   +5 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

Development of a Unified Reversed-Phase HPLC Method for Efficient Determination of EP and USP Process-Related Impurities in Celecoxib Using Analytical Quality by Design Principles

Molecules, 2020
This article presents the development of a reversed-phase (RP) high-performance liquid chromatographic (HPLC) method for determination of process-related impurities in a celecoxib drug substance following Analytical Quality by Design (AQbD) principles ...
Tim Tome, Zdenko Časar, Aleš Obreza
doaj   +1 more source

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

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

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, Mária Budai-Szűcs, Erzsébet Csányi, Szilvia Berkó, Péter Tonka-Nagy, Ildikó Csóka, Anita Kovács   +6 more
openaire   +4 more sources

Development of a Stability-Indicating Analytical Method for Determination of Venetoclax Using AQbD Principles [PDF]

ACS Omega, 2020
Venetoclax is an emerging drug for the treatment of various types of blood cancers. It was first approved in 2016 for the treatment of relapsed and refractory chronic lymphocytic leukemia. Later, the indications expanded, and multiple research as well as clinical studies are still conducted involving venetoclax.
Nina Žigart, Zdenko Časar
openaire   +3 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

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