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Analytical Similarity Assessment in Biosimilar Product Development

By Shein-Chung Chow

Release : 2018-09-03

Genre : Mathematics, Books, Science & Nature, Professional & Technical, Medical, Pharmacology & Toxicology, Biology

Kind : ebook

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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.

Analytical Similarity Assessment in Biosimilar Product Development

By Shein-Chung Chow

Release : 2018-09-03

Genre : Mathematics, Books, Science & Nature, Professional & Technical, Medical, Pharmacology & Toxicology, Biology

Kind : ebook

(0 ratings)
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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