Analytical Similarity Assessment in Biosimilar Product Development
- CategoryOther
- TypeE-Books
- LanguageEnglish
- Total size8.5 MB
- Uploaded Byfreecoursewb
- Downloads13
- Last checkedJun. 09th '22
- Date uploadedJun. 07th '22
- Seeders 4
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Analytical Similarity Assessment in Biosimilar Product Development 
https://TutGator.com
English | 2018 | ISBN: 9780203705131 | 354 pages | True PDF | 8.46 MB
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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