Analytical Similarity Assessment in Biosimilar Product Development Paperback / softback
by Shein-Chung Chow
Paperback / softback
- Information
Description
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.
Information
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Out of StockMore expected soonContact us for further information
- Format:Paperback / softback
- Pages:340 pages
- Publisher:Taylor & Francis Ltd
- Publication Date:18/12/2020
- Category:
- ISBN:9780367733834
Other Formats
- Hardback from £132.17
- EPUB from £44.99
- PDF from £44.99
Information
-
Out of StockMore expected soonContact us for further information
- Format:Paperback / softback
- Pages:340 pages
- Publisher:Taylor & Francis Ltd
- Publication Date:18/12/2020
- Category:
- ISBN:9780367733834