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Quality by Design for Biopharmaceuticals by Anurag S. Rathore Hardcover | Indigo Chapters
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Quality by Design for Biopharmaceuticals by Anurag S. Rathore Hardcover | Indigo Chapters - new book

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… More...

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Quality By Design for Biopharmaceuticals Principles and Case Studies 1 Wiley Series in Biotechnology and Bioengineering - Paperback

2007, 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… More...

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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 - hardcover

2009

ISBN: 0470282339

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

NOT NEW BOOK. Shipping costs: 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 - 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 - hardcover

2009, ISBN: 0470282339

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

NEW BOOK. Shipping costs: 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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AS Rathore:
Quality by Design for Biopharmaceuticals ? Principles and Case Studies - hardcover

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

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.

Details of the book - Quality by Design for Biopharmaceuticals by Anurag S. Rathore Hardcover | Indigo Chapters


EAN (ISBN-13): 9780470282335
ISBN (ISBN-10): 0470282339
Hardcover
Paperback
Publishing year: 2009
Publisher: Anurag S. Rathore
288 Pages
Weight: 0,590 kg
Language: eng/Englisch

Book in our database since 2010-03-26T15:38:58-04:00 (New York)
Detail page last modified on 2023-06-18T09:41:45-04:00 (New York)
ISBN/EAN: 9780470282335

ISBN - alternate spelling:
0-470-28233-9, 978-0-470-28233-5
Alternate spelling and related search-keywords:
Book author: john wiley sons
Book title: studies design, looking design, principles design, name design, take away design, design doing, biotechnology and bioengineering, design quality value, biotechnology and biopharmaceuticals


Information from Publisher

Author: Anurag S. Rathore; Rohin Mhatre
Title: Wiley Series on Biotechnology; Quality by Design for Biopharmaceuticals - Principles and Case Studies
Publisher: Wiley-Interscience; John Wiley & Sons
312 Pages
Publishing year: 2009-07-10
Weight: 0,648 kg
Language: English
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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