Results 81 to 90 of about 299 (155)

ICH Q14-Based Development of a Chaotropic Chromatography Method for the Determination of Olanzapine and Its Two Oxidative Degradation Products in Tablets

open access: yesAnalytica
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
doaj   +1 more source

Review on - Analytical Quality by Design (AQbD) A Novel Approach for Method Development

open access: yes
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 ...
openaire   +2 more sources

Sustainable RP-UPLC analysis of Nirogacestat for desmoid tumors using quality-by-design and green analytical chemistry

open access: yesGreen Chemistry Letters and Reviews
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
doaj   +1 more source

RP-HPLC method development and validation of Abacavir, Lamivudine and Zidovudine in combined pharmaceutical dosage by analytical QbD

open access: yesDiscover Chemistry
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
doaj   +1 more source

A Comprehensive Review on Analytical Quality by Design (AQbD) in Product Development: A Scientific and Lifecycle Approach

open access: yes
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 ...
openaire   +2 more sources

ANALYTICAL QUALITY BY DESIGN (AQBD) BASED DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR FAVIPIRAVIR

open access: yes
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
openaire   +2 more sources

Development of a QAMS Analysis Method for Industrial Lanolin Alcohol Based on the Concept of Analytical Quality by Design

open access: yesSeparations
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
doaj   +1 more source

ANALYTICAL QUALITY BY DESIGN (AQBD) APPROACH IN UV SPECTROSCOPIC METHOD DEVELOPMENT: CURRENT TRENDS AND APPLICATIONS

open access: yes
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 ...
openaire   +2 more sources

STRATEGIC IMPLEMENTATION OF ANALYTICAL QUALITY BY DESIGN (AQbD) IN HPLC METHOD DEVELOPMENT FOR PHARMACEUTICAL QUALITY ASSURANCE: A COMPREHENSIVE REVIEW

open access: yes
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 ...
openaire   +1 more source

ANALYTICAL QUALITY BY DESIGN (AQBD) IN THE DEVELOPMENT AND VALIDATION OF CHROMATOGRAPHIC METHODS FOR FIXED-DOSE COMBINATIONS: A COMPREHENSIVE REVIEW

open access: yes
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
openaire   +2 more sources

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