{"product_id":"quality-by-design-for-biopharmaceuticals-principles-and-case-studies-9780470282335","title":"Quality by Design for Biopharmaceuticals: Principles and Case Studies","description":"\u003cp\u003e • Author(s): Anurag S. Rathore\u003cbr\u003e • Publisher: Wiley-Interscience\u003cbr\u003e • Publisher Imprint: Wiley-Interscience\u003cbr\u003e • BISAC: Pharmacy\u003c\/p\u003e\u003cp\u003e\u003cb\u003eThe concepts, applications, and practical issues of Quality by Design\u003c\/b\u003e  \u003c\/p\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  *The understanding and development of the product's critical quality attributes (CQA) *Development of the design space for a manufacturing process *How to employ QbD to design a formulation process *Raw material analysis and control strategy for QbD *Process Analytical Technology (PAT) and how it relates to QbD *Relevant PAT tools and applications for the pharmaceutical industry *The uses of risk assessment and management in QbD *Filing QbD information in regulatory documents *The application of multivariate data analysis (MVDA) to QbD  \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":"Wiley-Interscience","offers":[{"title":"Hardcover","offer_id":45202311381143,"sku":"9780470282335","price":14449.0,"currency_code":"INR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0666\/3471\/1191\/files\/9780470282335.webp?v=1767307741","url":"https:\/\/atlanticbooks.com\/products\/quality-by-design-for-biopharmaceuticals-principles-and-case-studies-9780470282335","provider":"Atlantic Books","version":"1.0","type":"link"}