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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Bibliographische Detailangaben

1. Verfasser:	Chow, Shein-Chung (VerfasserIn)
Format:	UnknownFormat
Sprache:	eng
Veröffentlicht:	Boca Raton, London, New York CRC Press, Taylor & Francis Group 2019
Schriftenreihe:	Champman & Hall/CRC biostatistics series
Schlagworte:	Drug development > Biosimilars > Bioäquivalenz > Nachweis
Online Zugang:	Inhaltstext
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