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Statistical Methods for Immunogenicity Assessment

Bag om Statistical Methods for Immunogenicity Assessment

A critical issue in the development of biologics, immunogenicity can cause early termination or limited use of the products if not managed well. This book shows how to use robust statistical methods for detecting, quantifying, assessing, and mitigating immunogenicity risk. Along with covering regulatory requirements, the authors discuss statisti

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  • Sprog:
  • Engelsk
  • ISBN:
  • 9780367737979
  • Indbinding:
  • Paperback
  • Sideantal:
  • 259
  • Udgivet:
  • 18. december 2020
  • Størrelse:
  • 156x234x0 mm.
  • Vægt:
  • 367 g.
  • 2-4 uger.
  • 18. december 2024
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A critical issue in the development of biologics, immunogenicity can cause early termination or limited use of the products if not managed well. This book shows how to use robust statistical methods for detecting, quantifying, assessing, and mitigating immunogenicity risk. Along with covering regulatory requirements, the authors discuss statisti

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