Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing

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  • Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing Book Detail

  • Author : Harry Yang
  • Release Date : 2016-11-30
  • Publisher : CRC Press
  • Genre : Mathematics
  • Pages : 278
  • ISBN 13 : 1315354454
  • File Size : 23,23 MB

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

Book Description: 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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