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@article{189480,
        author = {Vaibhavi Mohan Mane and Onkar Shivalal Gosavi and Vidya Arvind Bhosale and Amruta Dattatray Gaikwad and Abhijit Tanaji Ghotkar and Shrushti Satish Ghante and Snehal Yuvaraj Kumbhar},
        title = {QUALITY BY DESIGN (QBD) APPROACH FOR ANALYTICAL METHOD DEVELOPMENT IN PHARMACEUTICAL PRODUCTS.},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {7},
        pages = {7648-7654},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=189480},
        abstract = {Quality by Design (QbD) is an approach that has gained popularity in the field of pharmaceutical Analytical Method Development in an attempt to promote reliable method performance and good product quality. In contrast to the trial-and-error traditional method development practice, Analytical Quality by Design (AQbD) focuses on set goals, understanding the variables involved in the method, and method control. The QbD strategy is initiated by the development of the Analytical Target Profile (ATP), followed by the determination of the Critical Quality Attributes (CQAs), Critical Method Parameters (CMPs), and risk analysis employing appropriate techniques. The use of design of experiments and optimization techniques through the design of experiments facilitates optimization of robustness. The use of control strategy implementation is essential for ensuring consistent method performance in the analysis. This article will outline the concept, components, benefits, and future trends of the strategy in the development of the analytical method for pharmaceutical products.},
        keywords = {Quality by Design (QbD); Analytical Quality by Design (AQbD); Analytical Method Development; Pharmaceutical Analysis; Analytical Target Profile (ATP); Design of Experiments (DoE); Risk Assessment; Method Operable Design Region (MODR); Critical Quality Attributes (CQAs); Critical Method Parameters (CMPs); Method Lifecycle Management},
        month = {December},
        }