Store besparelser
Hurtig levering
Fri fragt over 499,-
Gemte
Log ind
0
Kurv
Kurv
Analytical Similarity Assessment in Biosimilar Product Development
Engelsk
Foto på vej
Specifikationer
Sprog:
Engelsk
Sider:
340
ISBN-13:
9780367733834
Indbinding:
Paperback
Udgave:
ISBN-10:
0367733838
Kategori:
Udg. Dato:
18 dec 2020
Længde:
0mm
Bredde:
156mm
Højde:
234mm
Forlag:
Taylor & Francis Ltd
Oplagsdato:
18 dec 2020
Forfatter(e):
Paperback
Format:

Om denne bog

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.


Forlags Vejl. pris
493,94 kr
Hos Booktok
561 kr
Læg i kurv nu
Sikker betaling
23 - 25 hverdage

Specifikationer
Sprog:
Engelsk
Sider:
340
ISBN-13:
9780367733834
Indbinding:
Paperback
Udgave:
ISBN-10:
0367733838
Kategori:
Udg. Dato:
18 dec 2020
Længde:
0mm
Bredde:
156mm
Højde:
234mm
Forlag:
Taylor & Francis Ltd
Oplagsdato:
18 dec 2020
Forfatter(e):
Finder produkter...
Kategori sammenhænge