Quality-by-design in pharmaceutical development

Jelena Djuris, Svetlana Ibric and Zorica Djuric,     Department of Pharmaceutical Technology and Cosmetology Faculty of Pharmacy University of Belgrade


This first chapter introduces the concept of quality-by-design (QbD) and its role in pharmaceutical product development. QbD assures the quality of a pharmaceutical product through scientific development and risk management tools, and will eventually enable real-time release, regardless of the formulation type. Several guidelines on pharmaceutical development, quality risk management, and pharmaceutical quality systems are presented that are applicable throughout the product lifecycle. Design space appointment and control strategies ...

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