RECENT RESEARCH ON QbD APPROACH IN FORMULATION DEVELOPMENT - A REVIEW
نویسندگان
چکیده
QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include defining a target product quality profile, designing product and manufacturing processes, identifying critical quality attributes, process parameters, and sources of variability and controlling manufacturing processes to produce consistent quality over time. Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. The concept and elements of QbD and its application in pharmaceutical product development along with recent research in this area are reviewed in this article.
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