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Quality by Design for Biopharmaceuticals: Principles and Case Studies - Anurag S. Rathore
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Anurag S. Rathore:

Quality by Design for Biopharmaceuticals: Principles and Case Studies - nouveau livre

ISBN: 9780470282335

ID: 681558811

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. 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. Buch (fremdspr.) Bücher>Fremdsprachige Bücher>Englische Bücher, John Wiley & Sons Inc

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Quality by Design for Biopharmaceuticals: Principles and Case Studies - Anurag S. Rathore; Rohin Mhatre
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Anurag S. Rathore; Rohin Mhatre:

Quality by Design for Biopharmaceuticals: Principles and Case Studies - livre d'occasion

ISBN: 0470282339

ID: 6799108

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 multiva allied health services,biological sciences,biotechnology,medical books,medicine,medicine and health sciences,pharmacology,pharmacy,science and math,science and math Biotechnology, Wiley-Interscience

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Quality by Design for Biopharmaceuticals - Rathore, Anurag S.; Mhatre, Rohin
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Rathore, Anurag S.; Mhatre, Rohin:
Quality by Design for Biopharmaceuticals - nouveau livre

ISBN: 9780470282335

ID: 468996

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 technology, and quality by design. He has authored more than 100 publications and presentations in these areas and serves on the editorial advisory boards for Biotechnology Progress, BioPharm International, Pharmaceutical Technology Europe, Journal of Biochemical and Biophysical Methods, and Separation and Purification Reviews . Rohin Mhatre is a Senior Director in the BioProcess Development department at Biogen Idec, Cambridge, Massachusetts, and has been with the company since 1996. His group is responsible for development of analytical methods and product characterization to support the process and formulation development of early and late stage clinical programs. Mhatre is also leading the QbD initiative within Biogen Idec. He has authored several publications and been an invited speaker to numerous scientific meetings. Science Science eBook, Wiley

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Quality by design for biopharmaceuticals - Rathore, A.S.
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Rathore, A.S.:
Quality by design for biopharmaceuticals - nouveau livre

ISBN: 9780470282335

ID: 766f52802e55face0fcdb82d50cefc0b

This is the first book that explains the underlying concepts of Quality by Design (QbD) and the practical aspects of implementing QbD in biopharmaceutical manufacturing. A systematic approach leads the reader through a process, outlining the understanding of the critical quality attributes of the molecule, the development of the design space to meet the quality attributes, filing of the QbD information in regulatory documents, risk management, and the application of QbD. Complete with real-world case studies, this is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students., [PU: Wiley]

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Quality by design for biopharmaceuticals
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Quality by design for biopharmaceuticals - nouveau livre

ISBN: 9780470282335

ID: Dccfa5db7a67245cb5a24fd01b41bb435

This is the first book that explains the underlying concepts of Quality by Design (QbD) and the practical aspects of implementing QbD in biopharmaceutical manufacturing. A systematic approach leads the reader through a process, outlining the understanding of the critical quality attributes of the molecule, the development of the design space to meet the quality attributes, filing of the QbD information in regulatory documents, risk management, and the application of QbD. Complete with real-world case studies, this is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students. NL true, [PU: Wiley]

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Détails sur le livre
Quality by Design for Biopharmaceuticals: Principles and Case Studies
Auteur:

Anurag S. Rathore, Rohin Mhatre

Titre:

Quality by Design for Biopharmaceuticals: Principles and Case Studies

ISBN:

0470282339

Informations détaillées sur le livre - Quality by Design for Biopharmaceuticals: Principles and Case Studies


EAN (ISBN-13): 9780470282335
ISBN (ISBN-10): 0470282339
Version reliée
Date de parution: 2009
Editeur: John Wiley & Sons
288 Pages
Poids: 0,590 kg
Langue: eng/Englisch

Livre dans la base de données depuis 26.03.2010 20:38:58
Livre trouvé récemment le 14.01.2017 11:48:39
ISBN/EAN: 0470282339

ISBN - Autres types d'écriture:
0-470-28233-9, 978-0-470-28233-5

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