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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格式 EPUB ● 网页 354 ● ISBN 9781351339452 ● 出版者 CRC Press ● 发布时间 2018 ● 下载 3 时 ● 货币 EUR ● ID 6583603 ● 复制保护 Adobe DRM
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