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Analytical Quality by Design (AQbD) in HPLC Method Development: A Comprehensive Review of Principles, Tools, Regulatory Framework, and Emerging Applications

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Over the past two decades, pharmaceutical analytical science has undergone a quiet but consequential transformation in how methods are conceived, developed, and sustained across their operational lifetimes. The emergence of Analytical Quality by Design (AQbD) as a governing philosophy — rather than a procedural formality or a regulatory concession ...
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