Original price was: $69.99.$24.99Current price is: $24.99.
Access Analytical Similarity Assessment in Biosimilar Product Development 1st Edition Now. Discount up to 90%
| Full Title | Analytical Similarity Assessment in Biosimilar Product Development 1st Edition |
|---|---|
| Author(s) | Shein-Chung Chow |
| Edition | 1st Edition |
| ISBN | 9781351339452, 9780367733834, 9781138307339, 9780203705131, 9781351339469, 9781351339445 |
| Publisher | Chapman & Hall |
| Format | PDF and EPUB |
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.
Book Instantly Available.
Safe Payment with PayPal and Stripe
24/7 Customer Service
