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Analytical Similarity Assessment in Biosimilar Product Development

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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  • Språk:
  • Engelska
  • ISBN:
  • 9780367733834
  • Format:
  • Häftad
  • Sidor:
  • 340
  • Utgiven:
  • 18. december 2020
  • Mått:
  • 156x234x0 mm.
  • Vikt:
  • 650 g.
  Fri leverans
Leveranstid: 2-4 veckor
Förväntad leverans: 17. december 2024

Beskrivning av 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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