Analytical Similarity Assessment in Biosimilar Product Development e-bog
436,85 DKK
(inkl. moms 546,06 DKK)
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...
E-bog
436,85 DKK
Forlag
Chapman and Hall/CRC
Udgivet
3 september 2018
Længde
340 sider
Genrer
MBGR1
Sprog
English
Format
pdf
Beskyttelse
LCP
ISBN
9781351339469
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.