Analytical Similarity Assessment in Biosimilar Product Development is popular PDF and ePub book, written by Shein-Chung Chow in 2018-09-03, it is a fantastic choice for those who relish reading online the Mathematics genre. Let's immerse ourselves in this engaging Mathematics book by exploring the summary and details provided below. Remember, Analytical Similarity Assessment in Biosimilar Product Development can be Read Online from any device for your convenience.
Analytical Similarity Assessment in Biosimilar Product Development Book PDF Summary
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.
Detail Book of Analytical Similarity Assessment in Biosimilar Product Development PDF
- Author : Shein-Chung Chow
- Release : 03 September 2018
- Publisher : CRC Press
- ISBN : 9781351339469
- Genre : Mathematics
- Total Page : 340 pages
- Language : English
- PDF File Size : 9,8 Mb
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