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Analytical Similarity Assessment in Biosimilar Product Development
- Binding:
- Paperback
- Pages:
- 340
- Published:
- December 18, 2020
- Dimensions:
- 156x234x0 mm.
- Weight:
- 453 g.
Delivery:
1-2 weeks
Expected delivery: October 14, 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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