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Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing by Harry Yang

Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing

by Harry Yang
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Book cover type: Paperback
  • ISBN13: 9780367736644
  • Binding: Paperback
  • Subject: N/A
  • Publisher: Taylor & Francis
  • Publisher Imprint: CRC Press
  • Publication Date:
  • Pages: 386
  • Original Price: GBP 51.99
  • Language: English
  • Edition: N/A
  • Item Weight: 600 grams
  • BISAC Subject(s): Probability & Statistics / General, Biostatistics, and Pharmacology

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.

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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