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Books > Medicine > General issues > Public health & preventive medicine > Epidemiology & medical statistics
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Analytical Similarity Assessment in Biosimilar Product Development (Paperback)
Loot Price: R1,716
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Analytical Similarity Assessment in Biosimilar Product Development (Paperback)
Expected to ship within 12 - 17 working days
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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.
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