ISBN: 9780470282335 - quality by design for biopharmaceuticals: principles and case studies (wiley series in biotechnology and bioengineering) (25 Ergebnisse)

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Hardback. Zustand: New. The concepts, applications, and practical issues of Quality by Design Quality 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. Quality by Design: Perspectives and Case Studies 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. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA)Development of the design space for a manufacturing processHow to employ QbD to design a formulation processRaw material analysis and control strategy for QbDProcess Analytical Technology (PAT) and how it relates to QbDRelevant PAT tools and applications for the pharmaceutical industryThe uses of risk assessment and management in QbDFiling QbD information in regulatory documentsThe application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.…

Zustand: New. pp. 328.

Zustand: New. Provides 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. Editor(s): Rathore, Anurag S.; Mhatre, Rohin. Series: Wiley Series in Biotechnology and Bioengineering. Num Pages: 312 pages, Illustrations. BIC Classification: MBGR1; PN. Category: (P) Professional & Vocational. Dimension: 242 x 156 x 22. Weight in Grams: 588. . 2009. 1st Edition. Hardcover. . . . . …

Zustand: New. pp. 328.

Zustand: New. Anurag S. Rathore received his PhD in chemical engineering from Yale University and is the Director of Process Development, Amgen Inc. His areas of interest include process development, scale-up, technology transfer, process validation, process analytical t.

Hardcover. Zustand: Brand New. new edition. 288 pages. 9.75x6.50x1.00 inches. In Stock.

Zustand: New. Provides 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. Editor(s): Rathore, Anurag S.; Mhatre, Rohin. Series: Wiley Series in Biotechnology and Bioengineering. Num Pages: 312 pages, Illustrations. BIC Classification: MBGR1; PN. Category: (P) Professional & Vocational. Dimension: 242 x 156 x 22. Weight in Grams: 588. . 2009. 1st Edition. Hardcover. . . . . Books ship from the US and Ireland. …

Buch. Zustand: Neu. Neuware - The concepts, applications, and practical issues of Quality by Design Quality 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. Quality by Design: Perspectives and Case Studies 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. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: 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 Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.…

Hardback. Zustand: New. The concepts, applications, and practical issues of Quality by Design Quality 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. Quality by Design: Perspectives and Case Studies 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. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA)Development of the design space for a manufacturing processHow to employ QbD to design a formulation processRaw material analysis and control strategy for QbDProcess Analytical Technology (PAT) and how it relates to QbDRelevant PAT tools and applications for the pharmaceutical industryThe uses of risk assessment and management in QbDFiling QbD information in regulatory documentsThe application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.…

Hardback. Zustand: New. This item is printed on demand. New copy - Usually dispatched within 5-9 working days 664.

Hardcover. Zustand: new. Hardcover. The concepts, applications, and practical issues of Quality by Design Quality 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. Quality by Design: Perspectives and Case Studies 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. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA)Development of the design space for a manufacturing processHow to employ QbD to design a formulation processRaw material analysis and control strategy for QbDProcess Analytical Technology (PAT) and how it relates to QbDRelevant PAT tools and applications for the pharmaceutical industryThe uses of risk assessment and management in QbDFiling QbD information in regulatory documentsThe application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students. Provides 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. This item is printed on demand. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability.…

Hardcover. Zustand: Brand New. new edition. 288 pages. 9.75x6.50x1.00 inches. In Stock. This item is printed on demand.

Zustand: New. PRINT ON DEMAND pp. 328.