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@article{188322,
        author = {Kalyani Kasetti and Abhiram O and Abhi Chandana P and Bharat M},
        title = {AN OVERVIEW OF ANALYTICAL QUALITY BY DESIGN},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {7},
        pages = {1620-1631},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=188322},
        abstract = {By combining systematic risk assessment with in-depth method knowledge, Analytical Quality by Design (AQbD) creates an organized, scientific foundation for creating dependable and robust analytical techniques. This strategy, which emphasizes method control, A consistency, and lifecycle management, is in line with ICH Q8–Q10. Important components including the Analytical Target Profile (ATP), Critical Quality Attributes (CQAs), Critical Analytical Attributes (CAAs), and Critical Method Variables (CMVs) are well specified within the AQbD architecture. The Method Operable Design Region (MODR) is created utilizing risk-driven assessments in conjunction with Design of Experiments (DoE) techniques, such as factorial, Plackett–Burman, and Box–Behnken designs, to produce reliable and repeatable method performance. A well-established control strategy, combined with provisions for continual improvement, further strengthens method reliability and regulatory flexibility. By integrating statistical evaluation with scientific understanding, AQbD promotes proactive quality assurance and ensures that analytical methods remain consistent and compliant throughout the product lifecycle.},
        keywords = {Analytical Quality by Design, Analytical Target Profile, Critical Quality Attributes},
        month = {December},
        }