Analytical Method Development for 19 Alkyl Halides as Potential Genotoxic Impurities by Analytical Quality by Design [PDF]
Molecules, 2022 Major issues in the pharmaceutical industry involve efficient risk management and control strategies of potential genotoxic impurities (PGIs). As a result, the development of an appropriate method to control these impurities is required.
Kyoungmin Lee +2 more
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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.
Geonha Park +4 more
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Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics [PDF]
International Journal of Analytical Chemistry, 2015 Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach.
Ramalingam Peraman +2 more
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Rheology of Complex Topical Formulations: An Analytical Quality by Design Approach to Method Optimization and Validation [PDF]
Pharmaceutics, 2023 Analytical method validation ensures that a method provides trustworthy information about a particular sample when applied in accordance with the predefined protocol. According to regulatory standards, the rheological characteristics of topically applied
Lucas Chiarentin +3 more
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Analytical quality by design based on design space in reversed-phase-high performance liquid chromatography analysis for simultaneous estimation of metformin, linagliptin and empagliflozin [PDF]
Royal Society Open Science, 2022 Employing the Quality by Design paradigm through this work helped conclude the method operable design region for optimizing the high performance liquid chromatography (HPLC) assay using Design of Experiments and response surface methodology to obtain a ...
Aya A. Marie +4 more
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Important Aspects of the Design of Experiments and Data Treatment in the Analytical Quality by Design Framework for Chromatographic Method Development [PDF]
MoleculesIn the analytical quality by design (AQbD) framework, the design of experiments (DOE) plays a very important role, as it provides information about how experimental input variables influence critical method attributes.
Bianca F. G. Passerine +1 more
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Development and Validation of an in-line API Quantification Method Using AQbD Principles Based on UV-Vis Spectroscopy to Monitor and Optimise Continuous Hot Melt Extrusion Process [PDF]
Pharmaceutics, 2020 A key principle of developing a new medicine is that quality should be built in, with a thorough understanding of the product and the manufacturing process supported by appropriate process controls. Quality by design principles that have been established
Juan Almeida +5 more
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HPLC method development for fampridine using Analytical Quality by Design approach [PDF]
Acta Pharmaceutica, 2020 Offering a systematic and multivariate analysis of the analytical procedure, development and validation of HPLC methods using Quality by Design approach are in the limelight of current research trends.
Kovács Béla +6 more
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Analytical Quality by Design: Achieving Robustness of an LC-CAD Method for the Analysis of Non-Volatile Fatty Acids [PDF]
Pharmaceuticals, 2023 An alternative to the time-consuming and error-prone pharmacopoeial gas chromatography method for the analysis of fatty acids (FAs) is urgently needed.
Rasmus Walther +7 more
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Integrating analytical quality by design into bioanalytical method development: an HPLC-FLD method for quantification of alectinib in biological matrix [PDF]
BMC ChemistryThis study presents the development and validation of a fluorescence-based high-performance liquid chromatography (HPLC) method for the quantification of alectinib in rat plasma, with a focus on the application of Analytical Quality by Design (AQbD) to ...
Eun Ji Lee +4 more
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