Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing (Chapman & Hall/CRC Biostatistics Series)

Yang, Harry

ISBN 10: 0367736640 / ISBN 13: 9780367736644

Published by Routledge, 2020

About this Item

Seller Inventory # I-9780367736644

Bibliographic Details

• Title: Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing (Chapman & Hall/CRC Biostatistics Series)
• Publisher: Routledge
• Publication Date: 2020
• Language: English
• ISBN 10: 0367736640
• ISBN 13: 9780367736644
• Binding: Soft cover
• Condition: 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.