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Quality by Design for Biopharmaceuticals: Principles and Case Studies

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 | #1187099 in Books |  Wiley-Interscience |  2009-06-22 | Original language:English | PDF # 1 |  9.50 x.75 x6.30l,1.30 | File type: PDF | 328 pages

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||0 of 0 people found the following review helpful.| Worth reading, and has good coverage of topics.|By Donart Caledonian|Worth reading, and has good coverage of topics. It does begin getting thin towards the end, but if you are reading this review you probably already know you should buy this book.|0 of 0 people found the following review helpful.| Must-read for those implementing QbD in Biologics

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 produc...

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