Results 161 to 170 of about 833 (196)
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A Review on Advancement in Analytical Quality by Design (AQbD)
Current Analytical ChemistryAnalytical Quality by Design (AQbD) represents a transformative methodology in pharmaceutical development, anchored in a systematic, risk-based, and data-driven framework. This approach optimizes analytical methods, fostering heightened product quality, efficient regulatory compliance, and informed decision ...
Ankit Kumar Singh +4 more
exaly +2 more sources
Organic Process Research and Development, 2021
Drug substance stability-indicating methods (SIMs) must undergo a litany of optimization and robustness stresses to ensure that the methods can be successfully validated, transferred, and routinely...
Elizabeth M Yuill +2 more
exaly +2 more sources
Drug substance stability-indicating methods (SIMs) must undergo a litany of optimization and robustness stresses to ensure that the methods can be successfully validated, transferred, and routinely...
Elizabeth M Yuill +2 more
exaly +2 more sources
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.
Selvakumar Kanthiah, J.Joysa Ruby
exaly +3 more sources
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.
Selvakumar Kanthiah, J.Joysa Ruby
exaly +3 more sources
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.
Vera Moura +2 more
exaly +3 more sources
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.
Vera Moura +2 more
exaly +3 more sources
Development of a buccal in vitro permeation method – exploring aQbD implementation
International Journal of Pharmaceutics, 2023The 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 +6 more
openaire +2 more sources
Analytical quality by design (AQbD) in the ICHQ14 guidelines for analytical procedure development
Accreditation and Quality AssuranceKiranmayi Sathuluri +6 more
exaly +2 more sources
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 +3 more
openaire +2 more sources
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 +3 more
openaire +2 more sources
aQbD as a platform for IVRT method development – A regulatory oriented approach
International Journal of Pharmaceutics, 2019The 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 +3 more
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A Robust HPLC Method for the Simultaneous Determination of Finerenone and Its Enantiomer Using AQbD
ChiralityABSTRACTThe 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 +1 more
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An Estimation of Baricitinib by AQbD-driven UV Spectrophotometry Development and Validation Process
Letters in Drug Design & DiscoveryBackground: 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 +4 more
openaire +1 more source