Analytical Similarity Assessment in Biosimilar Product Development EPUB
by Shein-Chung Chow
EPUB
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.
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Download - Immediately Available
- Format:EPUB
- Pages:354 pages
- Publisher:CRC Press
- Publication Date:03/09/2018
- Category:
- ISBN:9781351339452
Other Formats
- PDF from £39.68
Information
-
Download - Immediately Available
- Format:EPUB
- Pages:354 pages
- Publisher:CRC Press
- Publication Date:03/09/2018
- Category:
- ISBN:9781351339452