Shein-Chung Chow
Analytical Similarity Assessment in Biosimilar Product Development
Paperback EN 2020 9780367733834Niet leverbaar.
Samenvatting
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.
Specificaties
ISBN13:9780367733834
Taal:EN
Bindwijze:Paperback
Aantal pagina's:340
Uitgever:Taylor & Francis Ltd
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