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Analytical Similarity Assessment in Biosimilar Product Development, Hardback Book

Analytical Similarity Assessment in Biosimilar Product Development Hardback


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.


  • Format: Hardback
  • Pages: 340 pages, 70 Tables, black and white
  • Publisher: Taylor & Francis Ltd
  • Publication Date:
  • Category: Epidemiology & medical statistics
  • ISBN: 9781138307339



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