Title: Emerging Non-clinical Biostatistics in Biopharmaceutical Development and Manufacturing
Publisher: Routledge
Publication Date: 2020
Language: English
ISBN 10: 0367736640
ISBN 13: 9780367736644
Binding: Soft cover
Condition: As New

About this title

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.

About the Author

Harry Yang, Ph.D., is senior director and head of the Non-Clinical Biostatistics Group at MedImmune, the global biologics arm of AstraZeneca headquartered in Gaithersburg, Maryland.

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