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Analytical Similarity Assessment in Biosimilar Product Development

af Shein-Chung Chow
Analytical Similarity Assessment in Biosimilar Product Development af Shein-Chung Chow
Bag om Analytical Similarity Assessment in Biosimilar Product Development

Focuses on analytical similarity assessment in biosimilar product development following the FDA's recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It will cover current issues, and recent development in analytical similarity assessment.

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  • Sprog:
  • Engelsk
  • ISBN:
  • 9780367733834
  • Indbinding:
  • Paperback
  • Sideantal:
  • 340
  • Udgivet:
  • 18. december 2020
  • Størrelse:
  • 156x234x0 mm.
  • Vægt:
  • 650 g.
  • 2-4 uger.
  • 18. december 2024
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Focuses on analytical similarity assessment in biosimilar product development following the FDA's recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It will cover current issues, and recent development in analytical similarity assessment.

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