Store besparelser
Hurtig levering
Fri fragt over 499,-
90 dages retur
Gemte
Log ind
0
Kurv
Kurv
Methodologies in Biosimilar Product Development
Engelsk
Bogcover for Methodologies in Biosimilar Product Development af , 9781032071800
Specifikationer
Sprog:
Engelsk
Sider:
380
ISBN-13:
9781032071800
Indbinding:
Paperback
ISBN-10:
103207180X
Kategori:
Udg. Dato:
25 sep 2023
Størrelse i cm:
23,3 x 15,7 x 2,4
Oplagsdato:
25 sep 2023

Methodologies in Biosimilar Product Development

Engelsk
Paperback 2023
Format:

Bog beskrivelse

Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product. These practical and challenging issues include, but are not limited to the mix-up use of interval hypotheses testing (i.e., the use of TOST) and confidence interval approach, a risk/benefit assessment for non-inferiority/similarity margin, PK/PD bridging studies with multiple references, the detection of possible reference product change over time, design and analysis of biosimilar switching studies, the assessment of sensitivity index for assessment of extrapolation across indications without collecting data from those indications not under study, and the feasibility and validation of non-medical switch post-approval.

Key Features:

  • Reviews withdrawn draft guidance on analytical similarity assessment.
  • Evaluates various methods for analytical similarity evaluation based on FDA’s current guidelines.
  • Provides a general approach for the use of n-of-1 trial design for assessment of interchangeability.
  • Discusses the feasibility and validity of the non-medical switch studies.
  • Provides innovative thinking for detection of possible reference product change over time.

This book embraces innovative thinking of design and analysis for biosimilar studies, which are required for review and approval of biosimilar regulatory submissions.

... Vis mere

Forlags Vejl. pris
535,89 kr
Hos Booktok
471 kr
spar 12%
Læg i kurv nu
Sikker betaling
90 dages retur
23 - 25 hverdage

Specifikationer
Sprog:
Engelsk
Sider:
380
ISBN-13:
9781032071800
Indbinding:
Paperback
ISBN-10:
103207180X
Kategori:
Udg. Dato:
25 sep 2023
Størrelse i cm:
23,3 x 15,7 x 2,4
Oplagsdato:
25 sep 2023
Finder produkter...
Kategori sammenhænge