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Quality by Design for Biopharmaceuticals - Principles and Case Studies

Language EnglishEnglish
Book Hardback
Book Quality by Design for Biopharmaceuticals - Principles and Case Studies Anurag S. Rathore
Libristo code: 04882679
Publishers John Wiley & Sons Inc, July 2009
This is the first book that explains the underlying concepts of Quality by Design (QbD) and the prac... Full description
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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.

About the book

Full name Quality by Design for Biopharmaceuticals - Principles and Case Studies
Author Anurag S. Rathore
Language English
Binding Book - Hardback
Date of issue 2009
Number of pages 312
EAN 9780470282335
ISBN 0470282339
Libristo code 04882679
Publishers John Wiley & Sons Inc
Weight 588
Dimensions 156 x 242 x 22

Categories

Mathematics & Science > Biology, life sciences
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