Analytical Similarity Assessment in Biosimilar Product Development PDF
by Shein-Chung Chow
- 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
-
Download Now
- Format:PDF
- Pages:354 pages
- Publisher:CRC Press
- Publication Date:03/09/2018
- Category:
- ISBN:9781351339469
Other Formats
- Paperback / softback from £43.18
- Hardback from £132.17
- EPUB from £44.99
Information
-
Download Now
- Format:PDF
- Pages:354 pages
- Publisher:CRC Press
- Publication Date:03/09/2018
- Category:
- ISBN:9781351339469