Quality by Design and Marketing
摘要
Critical scientific, technological, and regulatory constraints in pharmaceuticals’ study, development, and marketing must be addressed using a more comprehensive, systematic, integrated science and risk-based approach, such as Quality by Design (QbD). Consistent, dependable, and high-quality pharmaceutical goods are ensured by a greater understanding of the product and process of those results from applying the QbD approach. Additionally, this strategy encourages innovation and ongoing product improvement across the whole product lifecycle. Regulatory agencies strongly advise QbD-based submission for the effective transition of pharmaceuticals from laboratory-scale research to the pharmaceutical market with the necessary quality, safety, and efficacy standards. Two crucial steps in generating customer value are identifying quality standards through relationship quality management and transitioning from marketing innovation. Customer value creation is the goal of quality management, according to QbD tools. The current chapter deals with a complete understanding of QbD tools and their role in the management and advancement of the marketing of pharmaceuticals in each category.