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Analytical Similarity Assessment in Biosimilar Product Development
Shein-Chung Chow
(Author)
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CRC Press
· Hardcover
Analytical Similarity Assessment in Biosimilar Product Development - Chow, Shein-Chung
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Synopsis "Analytical Similarity Assessment in Biosimilar Product Development"
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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All books in our catalog are Original.
The book is written in English.
The binding of this edition is Hardcover.
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