Analytical Similarity Assessment in Biosimilar Product Development Hardback
by Shein-Chung Chow
Hardback
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
-
Available to Order - This title is available to order, with delivery expected within 2 weeks
- Format:Hardback
- Pages:340 pages, 70 Tables, black and white
- Publisher:Taylor & Francis Ltd
- Publication Date:01/08/2018
- Category:
- ISBN:9781138307339
Other Formats
- Paperback / softback from £46.35
- EPUB from £44.99
- PDF from £44.99
Information
-
Available to Order - This title is available to order, with delivery expected within 2 weeks
- Format:Hardback
- Pages:340 pages, 70 Tables, black and white
- Publisher:Taylor & Francis Ltd
- Publication Date:01/08/2018
- Category:
- ISBN:9781138307339