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Biosimilarity
- The FDA Perspective
Engelsk
Bogcover for Biosimilarity af Sarfaraz K. Niazi, 9781032652351
Specifikationer
Sprog:
Engelsk
Sider:
436
ISBN-13:
9781032652351
Indbinding:
Paperback
ISBN-10:
1032652357
Udg. Dato:
2 okt 2023
Størrelse i cm:
25,4 x 17,8
Oplagsdato:
2 okt 2023
Forfatter(e):

Biosimilarity

- The FDA Perspective
Engelsk
Paperback 2023
Format:

Bog beskrivelse

Summary:



The focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. Understanding the limitations of the statutory limits and non-inferiority testing are presented as tools to obviate patient trials and minimize testing of immunogenicity. An in-depth scientific, mathematical and statistical view of the tools required to establish biosimilarity of biological drugs of different complexity -- a must for every developer of biosimilars.



Features:



First comprehensive analysis based on new guidelines and approval packages of several biosimilars



Presents the first approach to challenge FDA in reducing or eliminating any testing in patients.



Provides a comprehensive understanding of the U.S. statutory requirements vis-a-vis the regulatory guidelines



Provides model CQA and Analytical Similarity testing protocols for cytokines and monoclonal antibodies



Allow creation of a fast-to-market pathway to develop biosimilars

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Specifikationer
Sprog:
Engelsk
Sider:
436
ISBN-13:
9781032652351
Indbinding:
Paperback
ISBN-10:
1032652357
Udg. Dato:
2 okt 2023
Størrelse i cm:
25,4 x 17,8
Oplagsdato:
2 okt 2023
Forfatter(e):
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