Analytical Similarity Assessment in Biosimilar Product Development Hardback
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.
- Format: Hardback
- Pages: 340 pages, 70 Tables, black and white
- Publisher: Taylor & Francis Ltd
- Publication Date: 01/08/2018
- Category: Epidemiology & medical statistics
- ISBN: 9781138307339