(DOWNLOAD) "Analytical Similarity Assessment in Biosimilar Product Development" by Shein-Chung Chow " eBook PDF Kindle ePub Free
eBook details
- Title: Analytical Similarity Assessment in Biosimilar Product Development
- Author : Shein-Chung Chow
- Release Date : January 03, 2018
- Genre: Mathematics,Books,Science & Nature,Professional & Technical,Medical,Pharmacology & Toxicology,
- Pages : * pages
- Size : 8437 KB
Description
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.
 "Analytical Similarity Assessment in Biosimilar Product Development" by Shein-Chung Chow " eBook PDF Kindle ePub Free){kind=link}