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Analytical Similarity Assessment in Biosimilar Product Development

av Shein-Chung (Duke Univ Chow
Analytical Similarity Assessment in Biosimilar Product Development av Shein-Chung (Duke Univ Chow
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:
  • 453 g.
  Fri leverans
Leveranstid: 2-4 veckor
Förväntad leverans: 24 Juli 2024

Om Shein-Chung (Duke Univ Chow

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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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