Detalls del llibre
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.
- Autor/a Shein-Chung Chow
- ISBN13 9781138307339
- ISBN10 1138307335
- Pàgines 340
- Any Edició 2018
- Fecha de publicación 01/08/2018
Ressenyes i valoracions
Analytical Similarity Assessment in Biosimilar Product Development
- De
- Shein-Chung Chow
- |
- ROUTLEDGE (2018)
- 9781138307339



