ISBN: 9780470282335
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 regulat… Mehr…
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Quality By Design for Biopharmaceuticals Principles and Case Studies 1 Wiley Series in Biotechnology and Bioengineering - Taschenbuch
2007, ISBN: 9780470282335
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2009, ISBN: 0470282339
[EAN: 9780470282335], Used, as new, [PU: Wiley-Interscience], Unread book in perfect condition., Books
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2009, ISBN: 0470282339
[EAN: 9780470282335], New book, [PU: Wiley-Interscience], Books
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2009, ISBN: 9780470282335
Buch, Hardcover, [PU: John Wiley & Sons Inc], John Wiley & Sons Inc, 2009
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Quality by Design for Biopharmaceuticals by Anurag S. Rathore Hardcover | Indigo Chapters - neues Buch
ISBN: 9780470282335
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 regulat… Mehr…
As Rathore:
Quality By Design for Biopharmaceuticals Principles and Case Studies 1 Wiley Series in Biotechnology and Bioengineering - Taschenbuch2007, ISBN: 9780470282335
Softcover, PLEASE NOTE, WE DO NOT SHIP TO DENMARK. New Book. Shipped from UK in 4 to 14 days. Established seller since 2000. Please note we cannot offer an expedited shipping service from… Mehr…
2009
ISBN: 0470282339
[EAN: 9780470282335], Used, as new, [PU: Wiley-Interscience], Unread book in perfect condition., Books
2009, ISBN: 9780470282335
Buch, Hardcover, [PU: John Wiley & Sons Inc], John Wiley & Sons Inc, 2009
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Detailangaben zum Buch - Quality by Design for Biopharmaceuticals by Anurag S. Rathore Hardcover | Indigo Chapters
EAN (ISBN-13): 9780470282335
ISBN (ISBN-10): 0470282339
Gebundene Ausgabe
Taschenbuch
Erscheinungsjahr: 2009
Herausgeber: Anurag S. Rathore
288 Seiten
Gewicht: 0,590 kg
Sprache: eng/Englisch
Buch in der Datenbank seit 2010-03-26T20:38:58+01:00 (Berlin)
Detailseite zuletzt geändert am 2023-06-18T15:41:45+02:00 (Berlin)
ISBN/EAN: 0470282339
ISBN - alternative Schreibweisen:
0-470-28233-9, 978-0-470-28233-5
Alternative Schreibweisen und verwandte Suchbegriffe:
Autor des Buches: john wiley sons
Titel des Buches: studies design, looking design, principles design, name design, take away design, design doing, biotechnology and bioengineering, design quality value, biotechnology and biopharmaceuticals
Daten vom Verlag:
Autor/in: Anurag S. Rathore; Rohin Mhatre
Titel: Wiley Series on Biotechnology; Quality by Design for Biopharmaceuticals - Principles and Case Studies
Verlag: Wiley-Interscience; John Wiley & Sons
312 Seiten
Erscheinungsjahr: 2009-07-10
Gewicht: 0,648 kg
Sprache: Englisch
155,00 € (DE)
Not available (reason unspecified)
172mm x 241mm x 23mm
BB; Hardcover, Softcover / Chemie; Industrielle Chemie und Chemietechnologie; Biopharmazie; Biotechnologie i. d. Chemie; Biotechnology; Chemie; Chemistry; Drug Discovery & Development; Pharmaceutical & Medicinal Chemistry; Pharmazeutische Industrie; Pharmazeutische u. Medizinische Chemie; Wirkstoffforschung u. -entwicklung; Biotechnologie i. d. Chemie; Pharmazeutische u. Medizinische Chemie; Wirkstoffforschung u. -entwicklung
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.Weitere, andere Bücher, die diesem Buch sehr ähnlich sein könnten:
Neuestes ähnliches Buch:
9780470466308 Quality by Design for Biopharmaceuticals (Anurag S. Rathore; Rohin Mhatre)
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