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Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing

Chapman & Hall/CRC Biostatistics Series

By (author) Harry Yang
Format: Hardback
Publisher: Taylor & Francis Inc, Portland, United States
Imprint: Productivity Press
Published: 1st Dec 2016
Dimensions: w 157mm h 241mm d 28mm
Weight: 738g
ISBN-10: 1498704158
ISBN-13: 9781498704151
Barcode No: 9781498704151
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Synopsis
The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and risk-based pharmaceutical development. A comprehensive resource, it combines in-depth explanations of advanced statistical methods with real-life case studies that illustrate practical applications of these methods in QbD implementation.

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