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Quality by Design for Biopharmaceuticals by Anurag S. Rathore Hardcover | Indigo Chapters - novo libro

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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… mais…

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

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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 - encadernado, livro de bolso

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 - encadernado, livro de bolso

2009, ISBN: 0470282339

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

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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 - encadernado, livro de bolso

2009, ISBN: 9780470282335

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Quality by Design for Biopharmaceuticals by Anurag S. Rathore Hardcover | Indigo Chapters
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0470282339


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.

Dados detalhados do livro - Quality by Design for Biopharmaceuticals by Anurag S. Rathore Hardcover | Indigo Chapters


EAN (ISBN-13): 9780470282335
ISBN (ISBN-10): 0470282339
Livro de capa dura
Livro de bolso
Ano de publicação: 2009
Editor/Editora: Anurag S. Rathore
288 Páginas
Peso: 0,590 kg
Língua: eng/Englisch

Livro na base de dados desde 2010-03-26T19:38:58+00:00 (Lisbon)
Página de detalhes modificada pela última vez em 2023-06-18T14:41:45+01:00 (Lisbon)
Número ISBN/EAN: 0470282339

Número ISBN - Ortografia alternativa:
0-470-28233-9, 978-0-470-28233-5
Ortografia alternativa e termos de pesquisa relacionados:
Autor do livro: john wiley sons
Título do livro: studies design, looking design, principles design, name design, take away design, design doing, biotechnology and bioengineering, design quality value, biotechnology and biopharmaceuticals

Dados da editora

Autor: Anurag S. Rathore; Rohin Mhatre
Título: Wiley Series on Biotechnology; Quality by Design for Biopharmaceuticals - Principles and Case Studies
Editora: Wiley-Interscience; John Wiley & Sons
312 Páginas
Ano de publicação: 2009-07-10
Peso: 0,648 kg
Língua: Inglês
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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