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Item Details
| Title:
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QUALITY BY DESIGN FOR BIOPHARMACEUTICALS
PRINCIPLES AND CASE STUDIES |
| By: |
Anurag S. Rathore (Editor), Rohin Mhatre (Editor), Anurag S. Rathore |
| Format: |
Hardback |
| List price:
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£129.95 |
| Our price: |
£116.96 |
| Discount: |
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| You save:
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£12.99 |
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| ISBN 10: |
0470282339 |
| ISBN 13: |
9780470282335 |
| Availability: |
Usually dispatched within 1-3 weeks.
 Delivery
rates
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| Stock: |
Currently 0 available |
| Publisher: |
JOHN WILEY AND SONS LTD |
| Pub. date: |
1 June, 2009 |
| Series: |
Wiley Series in Biotechnology and Bioengineering |
| Pages: |
312 |
| Description: |
Provides an in-depth understanding of the underlying concepts of Quality by Design (QbD) and the practical aspects of the implementation of QbD in biopharmaceutical manufacturing. |
| Synopsis: |
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. |
| Illustrations: |
Illustrations |
| Publication: |
US |
| Imprint: |
Wiley-Blackwell |
| Returns: |
Returnable |
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