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Quality is a prerequisite during entire drug development cycle. Clinical studies are required to prove effectiveness of experiment drug and to evaluate its safety profile in humans. To have a smooth design and conduct of clinical studies; Quality-by-Design (QbD) approach can be integrated with Quality Management System (QMS) to ensure the end-to-end quality optimization. Quality by Design is not widely used currently in clinical research.
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Varsha Choudhary (2021) studied this question.
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