Store besparelser
Hurtig levering
Fri fragt over 499,-
90 dages retur
Gemte
Log ind
0
Kurv
Kurv
Analytical Similarity Assessment in Biosimilar Product Development
Engelsk
Bogcover for Analytical Similarity Assessment in Biosimilar Product Development af Shein-Chung Chow, 9780367733834
Specifikationer
Sprog:
Engelsk
Sider:
340
ISBN-13:
9780367733834
Indbinding:
Paperback
ISBN-10:
0367733838
Kategori:
Udg. Dato:
18 dec 2020
Størrelse i cm:
23,4 x 15,6
Oplagsdato:
18 dec 2020
Forfatter(e):

Analytical Similarity Assessment in Biosimilar Product Development

Engelsk
Paperback 2020
Format:

Bog beskrivelse

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.

... Vis mere

Forlags Vejl. pris
617,45 kr
Hos Booktok
536 kr
spar 13%
Læg i kurv nu
Sikker betaling
90 dages retur
23 - 25 hverdage

Specifikationer
Sprog:
Engelsk
Sider:
340
ISBN-13:
9780367733834
Indbinding:
Paperback
ISBN-10:
0367733838
Kategori:
Udg. Dato:
18 dec 2020
Størrelse i cm:
23,4 x 15,6
Oplagsdato:
18 dec 2020
Forfatter(e):
Finder produkter...
Kategori sammenhænge