Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing

Yang, Harry

  • 出版商: CRC
  • 出版日期: 2020-12-18
  • 售價: $2,380
  • 貴賓價: 9.5$2,261
  • 語言: 英文
  • 頁數: 386
  • 裝訂: Quality Paper - also called trade paper
  • ISBN: 0367736640
  • ISBN-13: 9780367736644
  • 相關分類: 機率統計學 Probability-and-statistics
  • 海外代購書籍(需單獨結帳)

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商品描述

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.

作者簡介

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.