Analytical Similarity Assessment in Biosimilar Product Development
Analytical Similarity Assessment in Biosimilar Product Development
Click to enlarge
Author(s): Chow, Shein-Chung
ISBN No.: 9780367733834
Pages: 340
Year: 202012
Format: Trade Paper
Price: $ 80.21
Dispatch delay: Dispatched between 7 to 15 days
Status: Available (On Demand)

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.


To be able to view the table of contents for this publication then please subscribe by clicking the button below...
To be able to view the full description for this publication then please subscribe by clicking the button below...