Biosimilarity
The FDA Perspective
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.a 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 biosimilarsPresents the first approach to challenge FD…
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Noch nicht erschienen, Januar 2021
Produktdetails
- ISBN: 978-1-315-35137-7
- EAN: 9781315351377
- Produktnummer: 29181326
- Verlag: Taylor & Francis Ltd.
- Sprache: Englisch
- Erscheinungsjahr: 2018
- Seitenangabe: 436 S.
- Plattform: EPUB
- Abbildungen: 2 line equations and 2 total equations, 79 farbige Abbildungen
Über den Autor
Sarfaraz K. Niazi Ph.D, is Adjunct Professor at the faculty of University of Houston as well Chairman and President of Therapeutic Proteins Inc.
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