Analytical Similarity Assessment in Biosimilar Product Development

By Shein-Chung Chow

Analytical Similarity Assessment in Biosimilar Product Development - Shein-Chung Chow
  • Release Date: 2018-09-03
  • Genre: Mathematics

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.