| Title | : | Analytical Similarity Assessment in Biosimilar Product Development |
|---|---|---|
| Author | : | Shein-Chung Chow |
| Release | : | 2018-09-03 |
| Kind | : | ebook |
| Genre | : | Mathematics, Books, Science & Nature, Professional & Technical, Medical, Pharmacology & Toxicology, Biology |
| Size | : | 6818360 |
| 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. |
