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.
- ISBN13 9781351339445
- Publish Date 3 September 2018 (first published 8 August 2018)
- Publish Status Active
- Publish Country GB
- Publisher Taylor & Francis Ltd
- Imprint Chapman and Hall
- Format eBook
- Pages 340
- Language English