Analytical Similarity Assessment in Biosimilar Product Development
This book 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. Les mer
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This book 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 covers concepts such as the tiered approach for assessment of similarity of critical quality attributes in the manufacturing process of biosimilar products, models/methods like the statistical model for classification of critical quality attributes, equivalence tests for critical quality attributes in Tier 1 and the corresponding sample size requirements, current issues, and recent developments in analytical similarity assessment.
Detaljer
- Forlag
- Chapman & Hall/CRC
- Innbinding
- Paperback
- Språk
- Engelsk
- Sider
- 340
- ISBN
- 9780367733834
- Utgivelsesår
- 2020
- Format
- 23 x 16 cm