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.
General
Is the information for this product incomplete, wrong or inappropriate?
Let us know about it.
Does this product have an incorrect or missing image?
Send us a new image.
Is this product missing categories?
Add more categories.
Review This Product
No reviews yet - be the first to create one!
Welcome to Loot.co.za!
Sign in / Register |Wishlists & Gift Vouchers |Help | Advanced search
