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£171 today · usual range £150–£178 · best ever £150

CRC Press Analytical Similarity Assessment in Biosimilar Product Development

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£178.04 £147.20 £153.93 £160.66 £167.38 £174.11 £180.84 25 July 2026 09 August 2026 24 August 2026 08 September 2026 24 September 2026
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Price range: £150 - £178

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Description

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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