[DOWNLOAD] "Analytical Similarity Assessment in Biosimilar Product Development" by Shein-Chung Chow * Book PDF Kindle ePub Free

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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.

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