UID:
almahu_9949890626302882
Format:
1 online resource
ISBN:
9780203705131
,
0203705130
Series Statement:
Chapman & Hall/CRC biostatistics series
Content:
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.
Note:
Past experience for in vitro bioequivalence testing -- Regulatory approval pathway of biosimilar products -- CMC requirements -- Assay development and process validation -- Critical quality attributes -- FDA tiered approach for analytical assessment -- Sample size requirement -- Multiple references -- Extrapolation across indications -- Case studies -- FDA submissions -- Practical and challenging issues -- Recent development.
Language:
English
URL:
https://www.taylorfrancis.com/books/9780203705131
Bookmarklink
