Analytical Similarity Assessment in Biosimilar Product Development

1st Edition

Shein-Chung Chow

Chapman and Hall/CRC
Published August 1, 2018
Reference - 340 Pages
ISBN 9781138307339 - CAT# K35785

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Will be the first book focusing on analytical similarity assessment in biosimilar product development

Emphasizes the concept of variability associated with estimated equivalence acceptance criterion (EAC) for providing a more accurate and reliable assessment of the conducted analytical studies

Introduces FDA’s current thinking on the controversial issues

Provides a comprehensive review and comparison of various statistical methods


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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