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2000
Volume 21, Issue 8
  • ISSN: 1573-4110
  • E-ISSN: 1875-6727

Abstract

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-making. The industry's increasing acceptance of AQbD principles signifies a paradigm shift towards enhanced efficiency, sustainability, and global harmonization. This review comprehensively explores AQbD principles, regulatory perspectives, and its applications, particularly in analytical method development, including high-performance liquid chromatography (HPLC) and high-performance thin-layer chromatography (HPTLC). Emphasis is placed on the symbiotic relationship between AQbD and analytical method validation (AMV), elucidating their collective role in ensuring reliable and accurate analytical results. Integrating AQbD in method transfer, automation, and control strategies underscores its pivotal role in achieving robust, efficient, and compliant analytical processes. The review delves into lifecycle management and continuous improvement, coupled with AQbD principles, ensuring sustained method reliability throughout the pharmaceutical product lifecycle. AQbD's significant contribution to pharmaceutical lifecycle management, optimization, and change control is explored, emphasizing its systematic, data-driven, and risk-based approach to method development, validation, and ongoing enhancement. This review illuminates AQbD's transformative impact on pharmaceutical analysis, aligning with industry trends toward quality, efficiency, and regulatory compliance.

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A Review on Advancement in Analytical Quality by Design (AQbD)
Current Analytical Chemistry 21, 901 (2025); https://doi.org/10.2174/0115734110321580240924073705
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  • Article Type:     Review Article
Keyword(s): analytical method development; AQbD; critical method parameters; HPLC; pharmaceutical development; regulatory guidelines

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