Results 161 to 170 of about 796 (185)

Phytochemical Characterization of <i>Pouteria guianensis</i>: Optimized Flavonoid Extraction and HPLC Method Validation. [PDF]

ACS Omega
de Matos RC, Bitencourt AFA, de Oliveira ADM, Moreira CPS, Machado RR, Scopel M.   +5 more
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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
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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
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Leveraging AQbD Principles for Development of Challenging Drug Substance Stability-Indicating Methods

Organic Process Research & 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, Kevin M. Ileka, Thomas E. La Cruz, Jieming Li, Jonathan G. Shackman, Peter I. Tattersall, Jia Zang   +6 more
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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
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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.
Selvakumar Kanthiah, J. Joysa Ruby, Hiriyanna SGB, Valliappan Kannappan   +3 more
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STABILITY INDICATING LIQUID CHROMATOGRAPHIC ASSESSMENT OF DOLUTEGRAVIR BY AQBD APPROACH – CENTRAL COMPOSITE DESIGN

INDIAN DRUGS, 2017
Based on the current regulatory requirements for analytical method development, a RP-HPLC method for quality control of dolutegravir in dosage form has been optimized using analytical quality by design (AQbD) approach. Experimental observations were analysed by full factorial experimental design in Sigmatech software with two variables (flow rate and %
G. Sunitha, P. D Anumolu, C.V.S Subrahmanyam, G Mounika, B. Priyanka   +4 more
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A Review on Advancement in Analytical Quality by Design (AQbD)

Current Analytical Chemistry
Analytical 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, Yogita Vashitha, Ashita Jain, Ghanshyam Das Gupta, Sant Kumar Verma   +4 more
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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.
Lucas Chiarentin, Vera Moura, Carla Vitorino   +2 more
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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
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