Analytical Similarity Assessment in Biosimilar Product Development

Analytical Similarity Assessment in Biosimilar Product Development

by Shein-Chung Chow
Epub (Kobo), Epub (Adobe)
Publication Date: 21/08/2018

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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.

ISBN:
9781351339452
9781351339452
Category:
Probability & statistics
Format:
Epub (Kobo), Epub (Adobe)
Publication Date:
21-08-2018
Language:
English
Publisher:
CRC Press

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