{"product_id":"quality-by-design-for-biopharmaceuticals","title":"Quality by Design for Biopharmaceuticals","description":"\u003cb\u003eThe concepts, applications, and practical issues of Quality by Design\u003c\/b\u003e  \u003cp\u003eQuality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process.\u003c\/p\u003e \u003cp\u003e\u003ci\u003eQuality by Design: Perspectives and Case Studies\u003c\/i\u003e presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation.\u003c\/p\u003e \u003cp\u003eIn this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as:\u003c\/p\u003e \u003cul\u003e\n\u003cli\u003eThe understanding and development of the product's critical quality attributes (CQA)\u003c\/li\u003e\n\u003cli\u003eDevelopment of the design space for a manufacturing process\u003c\/li\u003e\n\u003cli\u003eHow to employ QbD to design a formulation process\u003c\/li\u003e\n\u003cli\u003eRaw material analysis and control strategy for QbD\u003c\/li\u003e\n\u003cli\u003eProcess Analytical Technology (PAT) and how it relates to QbD\u003c\/li\u003e\n\u003cli\u003eRelevant PAT tools and applications for the pharmaceutical industry\u003c\/li\u003e\n\u003cli\u003eThe uses of risk assessment and management in QbD\u003c\/li\u003e\n\u003cli\u003eFiling QbD information in regulatory documents\u003c\/li\u003e\n\u003cli\u003eThe application of multivariate data analysis (MVDA) to QbD\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003eFilled with vivid case studies that illustrate QbD at work in companies today, \u003ci\u003eQuality by Design\u003c\/i\u003e is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.\u003c\/p\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Product","offer_id":54222495875416,"sku":"9780470282335","price":142.99,"currency_code":"EUR","in_stock":true}],"url":"https:\/\/agendabookshop.com\/products\/quality-by-design-for-biopharmaceuticals","provider":"Agenda Bookshop","version":"1.0","type":"link"}