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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… Altro …

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Quality By Design for Biopharmaceuticals Principles and Case Studies 1 Wiley Series in Biotechnology and Bioengineering - edizione con copertina flessibile

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Quality by Design for Biopharmaceuticals : Principles and Case Studies - Rathore, Anurag S. (EDT); Mhatre, Rohin (EDT)
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Rathore, Anurag S. (EDT); Mhatre, Rohin (EDT):
Quality by Design for Biopharmaceuticals : Principles and Case Studies - copertina rigida, flessible

2009

ISBN: 0470282339

[EAN: 9780470282335], Used, as new, [PU: Wiley-Interscience], Unread book in perfect condition., Books

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Quality by Design for Biopharmaceuticals : Principles and Case Studies - Rathore, Anurag S. (EDT); Mhatre, Rohin (EDT)
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Rathore, Anurag S. (EDT); Mhatre, Rohin (EDT):
Quality by Design for Biopharmaceuticals : Principles and Case Studies - copertina rigida, flessible

2009, ISBN: 0470282339

[EAN: 9780470282335], New book, [PU: Wiley-Interscience], Books

NEW BOOK. Costi di spedizione: EUR 2.64 GreatBookPrices, Columbia, MD, U.S.A. [5352716] [Rating: 5 (of 5)]
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Quality by Design for Biopharmaceuticals ? Principles and Case Studies - AS Rathore
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Quality by Design for Biopharmaceuticals ? Principles and Case Studies - copertina rigida, flessible

2009, ISBN: 9780470282335

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Quality by Design for Biopharmaceuticals by Anurag S. Rathore Hardcover | Indigo Chapters
Autore:
Titolo:
ISBN:

9780470282335


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.

Informazioni dettagliate del libro - Quality by Design for Biopharmaceuticals by Anurag S. Rathore Hardcover | Indigo Chapters


EAN (ISBN-13): 9780470282335
ISBN (ISBN-10): 0470282339
Copertina rigida
Copertina flessibile
Anno di pubblicazione: 2009
Editore: Anurag S. Rathore
288 Pagine
Peso: 0,590 kg
Lingua: eng/Englisch

Libro nella banca dati dal 2010-03-26T20:38:58+01:00 (Zurich)
Pagina di dettaglio ultima modifica in 2023-06-18T15:41:45+02:00 (Zurich)
ISBN/EAN: 9780470282335

ISBN - Stili di scrittura alternativi:
0-470-28233-9, 978-0-470-28233-5
Stili di scrittura alternativi e concetti di ricerca simili:
Autore del libro : john wiley sons
Titolo del libro: studies design, looking design, principles design, name design, take away design, design doing, biotechnology and bioengineering, design quality value, biotechnology and biopharmaceuticals

Dati dell'editore

Autore: Anurag S. Rathore; Rohin Mhatre
Titolo: Wiley Series on Biotechnology; Quality by Design for Biopharmaceuticals - Principles and Case Studies
Editore: Wiley-Interscience; John Wiley & Sons
312 Pagine
Anno di pubblicazione: 2009-07-10
Peso: 0,648 kg
Lingua: Inglese
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.

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