Analytical similarity assessment in biosimilar product development
"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 will cover current issues, and recent development in analytical similarity assessm...
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| Format: | UnknownFormat |
| Sprache: | eng |
| Veröffentlicht: |
Boca Raton, London, New York
CRC Press, Taylor & Francis Group
2019
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| Schriftenreihe: | Champman & Hall/CRC biostatistics series
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| Schlagworte: | |
| Online Zugang: | Inhaltstext |
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Tag hinzufügen | Zusammenfassung: | "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 will cover current issues, and recent development in analytical similarity assessment"-- 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 |
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| Beschreibung: | Literaturangaben |
| Beschreibung: | xiii, 339 Seiten Illustrationen |
| ISBN: | 9781138307339 978-1-138-30733-9 |