Abstract
Quality is the most important and necessary attribute for pharmaceutical product development, and it has become the focus of regulatory bodies in order to approve safe, efficacious, stable, patient-compliance, and cost-effective drug delivery systems. QbD-based formulation development is discovered to be an immerging technique in this context. FbD is a formulation development concept that aims to create more effective, safe, robust, cost-effective, and patient-compliant drug delivery systems. This chapter will provide an overview of Formulation by Design (FbD), different terminologies, design of experiment (DoE) and quality by design (QbD), types of experimental design, QbD applications, and FbD methodology along with benefits.
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