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Anurag S Rathore - Quality by Design for Biopharmaceuticals - 9780470282335 - V9780470282335
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Quality by Design for Biopharmaceuticals

€ 166.30
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Description for Quality by Design for Biopharmaceuticals Hardcover. 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. Editor(s): Rathore, Anurag S.; Mhatre, Rohin. Series: Wiley Series in Biotechnology and Bioengineering. Num Pages: 312 pages, Illustrations. BIC Classification: MBGR1; PN. Category: (P) Professional & Vocational. Dimension: 242 x 156 x 22. Weight in Grams: 588.
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 ... Read more

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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Product Details

Format
Hardback
Publication date
2009
Publisher
John Wiley and Sons Ltd United Kingdom
Number of pages
312
Condition
New
Series
Wiley Series in Biotechnology and Bioengineering
Number of Pages
312
Place of Publication
, United States
ISBN
9780470282335
SKU
V9780470282335
Shipping Time
Usually ships in 7 to 11 working days
Ref
99-50

About Anurag S Rathore
Anurag S. Rathore received his PhD in chemical engineering from Yale University and is the Director of Process Development, Amgen Inc. His areas of interest include process development, scale-up, technology transfer, process validation, process analytical technology, and quality by design. He has authored more than 100 publications and presentations in these areas and serves on the editorial advisory boards for ... Read more

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