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Quality by Design for Biopharmaceuticals

Principles and Case Studies

Anurag S. Rathore (Hrsg.), Rohin Mhatre (Hrsg.)

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John Wiley & Sons img Link Publisher

Naturwissenschaften, Medizin, Informatik, Technik / Chemie

Beschreibung

The concepts, applications, and practical issues of Quality byDesign Quality by Design (QbD) is a new framework currently beingimplemented by the FDA, as well as EU and Japanese regulatoryagencies, to ensure better understanding of the process so as toyield a consistent and high-quality pharmaceutical product. QbDbreaks from past approaches in assuming that drug quality cannot betested into products; rather, it must be built into every step ofthe product creation process. Quality by Design: Perspectives and Case Studies presentsthe first systematic approach to QbD in the biotech industry. Acomprehensive resource, it combines an in-depth explanation ofbasic concepts with real-life case studies that illustrate thepractical aspects of QbD implementation. In this single source, leading authorities from thebiotechnology industry and the FDA discuss such topics as: * The understanding and development of the product's criticalquality attributes (CQA) * Development of the design space for a manufacturingprocess * 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 toQbD * Relevant PAT tools and applications for the pharmaceuticalindustry * The uses of risk assessment and management in QbD * Filing QbD information in regulatory documents * The application of multivariate data analysis (MVDA) toQbD Filled with vivid case studies that illustrate QbD at work incompanies today, Quality by Design is a core reference forscientists in the biopharmaceutical industry, regulatory agencies,and students.

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Schlagwörter

Biotechnologie i. d. Chemie, Pharmaceutical & Medicinal Chemistry, Pharmazeutische u. Medizinische Chemie, Wirkstoffforschung u. -entwicklung, Biotechnology, Pharmazeutische Industrie, Biopharmazie, Chemistry, Chemie, Drug Discovery & Development