Analytical Similarity Assessment in Biosimilar Product Development

Analytical Similarity Assessment in Biosimilar Product Development

Shein, Chung Chow

Taylor & Francis (ML) , 2018

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O knihe

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.

Edícia: 1
EAN: 9781138307339
ISBN: 9781138307339
Vydavateľstvo: Taylor & Francis (ML)
Autori: Shein, Chung Chow
Rok vydania: 2018
Počet strán: 354
Väzba: Hardback
Rozmer: 240 x 162 x 26
Jazyk: Anglický jazyk

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