Analytical Similarity Assessment in Biosimilar Product Development

by Shein-Chung Chow

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...

• Format: Paperback
• Language: English
• ISBN: 0367733838
• ISBN13: 9780367733834
• Release Date: December 2020
• Publisher: CRC Press
• Length: 340 Pages
• Weight: 0.83 lbs.
• Dimensions: 0.8" x 6.1" x 9.1"