{"product_id":"9780470282335-quality-by-design","title":"Quality by Design for Biopharmaceuticals","description":"\u003cmeta content=\"text\/html; charset=utf-8\" http-equiv=\"Content-Type\"\u003e\u003cp\u003e\u003cspan\u003ePrinciples and Case Studies\u003cbr\u003eProvides an in-depth understanding of the underlying concepts of Quality by Design (QbD) and the practical aspects of the implementation of QbD in biopharmaceutical manufacturing.\u003cbr\u003e\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\n\u003cbr\u003e\u003cbr\u003e\u003c\/span\u003e\u003c\/p\u003e","brand":"Rarewaves","offers":[{"title":"Default Title","offer_id":40986708410465,"sku":"9780470282335","price":142.39,"currency_code":"GBP","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0092\/7504\/8033\/files\/orig_28024760.jpg?v=1722606289","url":"https:\/\/www.rarewaves.com\/products\/9780470282335-quality-by-design","provider":"Rarewaves.com","version":"1.0","type":"link"}