Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing

Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing

Forfatter: Harry Yang
Forlag: CRC Press
Utgave: 1
Utgivelsesår: 2016
ISBN: 9781498704151

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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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