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Analytical Similarity Assessment in Biosimilar Product Development

About 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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  • Language:
  • English
  • ISBN:
  • 9780367733834
  • Binding:
  • Paperback
  • Pages:
  • 340
  • Published:
  • December 17, 2020
  • Dimensions:
  • 156x234x0 mm.
  • Weight:
  • 650 g.
Delivery: 1-2 weeks
Expected delivery: December 6, 2024

Description of 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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