Results 131 to 140 of about 329 (162)

Navigating the AQbD Landscape: Enhancing Quality Management in Liquid Chromatography Method Development

Biomedical Chromatography
ABSTRACTThe implementation of ‘Analytical Quality by Design’ (AQbD) is currently recognised as a methodical and scientific approach to liquid chromatographic (LC) method development. It begins with defining the Analytical Target Profile (ATP), identifying Critical Method Parameters (CMPs) and Critical Quality Attributes (CQAs) or responses.
Valliappan Kannappan, J Joysa Ruby, Selvakumar Kanthiah   +2 more
exaly   +3 more sources

Mucoadhesion and rheology characterization in topical semisolid formulations: An AQbD-driven case study

International Journal of Pharmaceutics
This study outlines a framework for developing a texture analyzer-based mucoadhesion method integrated with rheology analysis for evaluating ointment formulations. Using an Analytical Quality by Design (AQbD) approach, key sources of variability affecting critical method variables (CMVs) were identified.
V Moura, Lucas Chiarentin, Carla Vitorino   +2 more
exaly   +3 more sources

Development of a buccal in vitro permeation method – exploring aQbD implementation

International Journal of Pharmaceutics, 2023
The buccal mucosa is arising within the pharmaceutical landscape as an attractive option for local and systemic drug delivery, mostly due to its high vascularization, inherent permeability and robustness. Still, one of the major challenges in bringing oromucosal preparations to market remains the accurate evaluation of permeability. During pre-clinical
Ariana Sena, Alain Costa, Francisca Bastos, Ana Catarina Pinto, Carla Vitorino, António Nunes, Sérgio Simões   +6 more
openaire   +2 more sources

Analytical quality by design (AQbD) in the ICHQ14 guidelines for analytical procedure development

Accreditation and Quality Assurance
Ramalingam Peraman, Ravichandiran V, Peraman Ramalingam   +2 more
exaly   +2 more sources

aQbD as a platform for IVRT method development – A regulatory oriented approach

International Journal of Pharmaceutics, 2019
The EMA draft guideline on quality and equivalence of topical products and the FDA non-binding product specific guidances release has encouraged the establishment of a regulatory background for in vitro release testing (IVRT). Herein, a novel framework applicable to the development of a discriminatory IVRT method is described, according to analytical ...
Margarida Miranda, Alberto A.C.C. Pais, Catarina Cardoso, Carla Vitorino   +3 more
openaire   +2 more sources

Chemometric-Based AQbD and Green Chemistry Approaches to Chromatographic Analysis of Remogliflozin Etabonate and Vildagliptin

Journal of AOAC INTERNATIONAL, 2022
Abstract Background According to the green chemistry approach, during method development, the usage of toxic and carcinogenic organic solvents should be avoided or minimized for the safety of the environment and analysts.
Pintu Prajapati, Hetal Ahir, Bhumika Prajapati, Shailesh Shah   +3 more
openaire   +2 more sources

AQbD‐Guided Chiral HPLC for Enantiomeric Impurity Analysis of Suzetrigine

Chirality
ABSTRACT Suzetrigine (SUZ), an analgesic for acute pain, requires strict enantiomeric purity control. This study develops a robust chiral HPLC method for SUZ and its R‐enantiomer using analytical quality by design (AQbD). Separation was achieved on a Chiralpak IC‐3 column with an isocratic n‐hexane–ethanol (90:10,
Sultanah M. N. Alhunayhin, Ayman M. Algohary, Saja A. Althobaiti, Abdullah H. Alluhayb, Mona I. Shahin, Ahmed M. Ibrahim, Tamer H. A. Hasanin   +6 more
openaire   +1 more source

A Robust HPLC Method for the Simultaneous Determination of Finerenone and Its Enantiomer Using AQbD

Chirality
ABSTRACTThe enantiomeric purity of Finerenone (FIN), a novel therapeutic for chronic kidney disease (CKD), is a critical quality attribute for ensuring patient safety. This study reports the first chiral HPLC method for the simultaneous determination of FIN and its enantiomer, developed and validated using a rigorous analytical quality by design (AQbD)
Badriah Saad Al‐Farhan, Ghada M. G. Eldin   +1 more
openaire   +2 more sources

An Estimation of Baricitinib by AQbD-driven UV Spectrophotometry Development and Validation Process

Letters in Drug Design & Discovery
Background: Baricitinib (BCTB) is a novel Janus Kinase (JAK) 1 and 2 inhibitor used in the therapy of rheumatoid arthritis, approved by the “Food and Drug Administration” in 2018. It has significant dose-dependent effectiveness and severe side effects. Thus, it is crucial to figure out its concentration in developed dosage forms. The literature search
Laxmi Rani, Ashwini Kumar Mishra, Neha S.L., Hitesh Kumar Dewangan, Pravat Kumar Sahoo   +4 more
openaire   +1 more source

Development of an AQbD driven HPLC method for the simultaneous estimation of caffeine and misoprostol in nanoparticle formulations

Analytical Methods
This graphical abstract depicts the HPLC-based simultaneous estimation of caffeine and misoprostol using, AQbD, followed by quantitative analysis of both drugs in chitosan based nanoparticles.
Nitasha Chauhan, Shiv Kumar, Shailendra Singh Rana, Shruti Chopra, Amit Bhatia   +4 more
openaire   +2 more sources