Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing

1st Edition

Harry Yang

Chapman and Hall/CRC
Published December 1, 2016
Reference - 386 Pages - 30 B/W Illustrations
ISBN 9781498704151 - CAT# K24701
Series: Chapman & Hall/CRC Biostatistics Series

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Summary

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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