Quality by Design for Biopharmaceuticals

Quality by Design for Biopharmaceuticals

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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 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… (more)

Book Details  

Publisher: Wiley-Interscience (September 19, 2011)

Collection: Wiley Series in Biotechnology and Bioengineering

Format: EPUB

Page count: 312 pages

File size: 16 MB

Protection: DRM

Language: English

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