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This is a Literature Review study.

September 10, 2025

Analytical Quality by Design (AQbD): A Comprehensive Review with Emphasis on Risk Assessment Approaches

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This review highlights the integration of risk assessment in analytical quality by design, showcasing its implications and applications.

AQbD enhances analytical methods' reliability, robustness, and compliance through risk-based approaches.
Key elements such as design of experiments and critical quality attributes are crucial in method development.
Risk assessment tools like FMEA and Ishikawa diagrams improve decision-making during the analytical lifecycle.
Implementation of AQbD aligns with global regulatory expectations, supporting sustainable method performance.

Jethava et al. (2025) studied this question.

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