Results 81 to 90 of about 299 (155)
Impurity profiling is of significant analytical and regulatory importance, particularly in the context of lifecycle quality management. A robust chaotropic chromatography method was developed for the determination of olanzapine and its two oxidative ...
Milena Rmandić +5 more
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Review on - Analytical Quality by Design (AQbD) A Novel Approach for Method Development
Analytical Quality by Design (AQbD) is a systematic, science- and risk-based approach for analytical method development that ensures robustness, reliability, and lifecycle management. Unlike traditional trial-and-error methods, AQbD focuses on predefined objectives, comprehensive method understanding, and statistical evaluation of method variables ...
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Quality-by-Design (QbD) and Green Analytical Chemistry (GAC) are used to develop a sustainable RP-UPLC method for detecting Nirogacestat hydrobromide (NGS) in bulk and pharmaceutical formulations.
Vanga Mohan Goud +4 more
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An accurate, precise, robust, and green RP-HPLC method was developed for assessment of three antiviral medications, namely Abacavir (ABA), Lamivudine (LAMI), and Zidovudine (ZIDO) in combined pharmaceutical dosage form by Analytical Quality by Design ...
Divyesh Vanparia +2 more
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Abstract: Analytical Quality by Design (AQbD) is a modern scientific approach that ensures analytical methods are developed, validated, and maintained using a systematic, risk-based framework throughout the product lifecycle. AQbD emphasizes product and process understanding, design of experiments (DoE), and continuous improvement, ensuring quality is ...
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Analytical Quality by Design (AQbD) is a systematic, science-based, and risk-management-oriented approach for developing robust analytical methods. The concept emphasizes predefined objectives, process understanding, and control strategies to ensure consistent analytical performance. Favipiravir, a broad-spectrum antiviral drug extensively investigated
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The Analytical Quality by Design (AQbD) concept was adopted to establish a quantitative analysis of multi-components with a single marker (QAMS) method for industrial lanolin alcohol, targeting cholesterol, lanosterol, and 24,25-dihydrolanosterol.
Kaidierya Abudureheman +3 more
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Analytical Quality by Design (AQbD) has become a structured, scientific and risk-based methodology of creating reliable and robust methodologies of analysis within the pharmaceutical industry. As opposed to traditional trial and error methods, AQbD combines preconceived goals, risk analysis tools and statistical optimization methods to provide ...
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The pharmaceutical sector is witnessing a fundamental transition from empirical "One- Factor-At-A-Time" (OFAT) methodologies toward the highly structured "Analytical Quality by Design" (AQbD) paradigm. This review aims to critically evaluate how AQbD enhances the robustness and reliability of High-Performance Liquid Chromatography (HPLC) methods ...
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The paradigm of pharmaceutical analysis is undergoing a critical transition from traditional empirical Quality by Testing (QbT) frameworks to systematic, risk-based methodologies encapsulated by the Analytical Quality by Design (AQbD) initiative. This shift is particularly crucial for Fixed-Dose Combinations (FDCs), where the simultaneous estimation of
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