Shein-Chung (Duke Univ, USA) Chow,
Shein-Chung Chow
Analytical Similarity Assessment in Biosimilar Product Development
Gebonden Engels 2018 1e druk 9781138307339Levertijd ongeveer 11 werkdagen
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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.
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