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. 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 FDA i…
Mehr
CHF 56.75
Preise inkl. MwSt. und Versandkosten (Portofrei ab CHF 40.00)
Versandkostenfrei
Produktdetails
- ISBN: 978-1-4987-5040-0
- EAN: 9781498750400
- Produktnummer: 29182110
- Verlag: Taylor & Francis Ltd.
- Sprache: Englisch
- Erscheinungsjahr: 2018
- Seitenangabe: 436 S.
- Plattform: PDF
- Masse: 34'153 KB
- Auflage: 1. Auflage
- 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.
59 weitere Werke von Sarfaraz K. Niazi:
Handbook of Pharmaceutical Manufacturing Formulations
The FDA Perspective
The FDA Perspective
Ebook (PDF Format)
CHF 81.25
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
The FDA Perspective
The FDA Perspective
Ebook (PDF Format)
CHF 81.25
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
The FDA Perspective
The FDA Perspective
Ebook (PDF Format)
CHF 81.25
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
The FDA Perspective
The FDA Perspective
Ebook (EPUB Format)
CHF 66.35
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
The FDA Perspective
The FDA Perspective
Ebook (PDF Format)
CHF 66.35
Handbook of Pharmaceutical Manufacturing Formulations
The FDA Perspective
The FDA Perspective
Ebook (PDF Format)
CHF 414.10
Handbook of Pharmaceutical Manufacturing Formulations
The FDA Perspective
The FDA Perspective
Ebook (PDF Format)
CHF 435.40
Handbook of Pharmaceutical Manufacturing Formulations
The FDA Perspective
The FDA Perspective
Ebook (PDF Format)
CHF 435.40
Handbook of Pharmaceutical Manufacturing Formulations
The FDA Perspective
The FDA Perspective
Ebook (PDF Format)
CHF 81.25
Handbook of Pharmaceutical Manufacturing Formulations
The FDA Perspective
The FDA Perspective
Ebook (PDF Format)
CHF 81.25
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
The FDA Perspective
The FDA Perspective
Ebook (EPUB Format)
CHF 81.25
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
The FDA Perspective
The FDA Perspective
Ebook (PDF Format)
CHF 81.25
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
The FDA Perspective
The FDA Perspective
Ebook (PDF Format)
CHF 66.35
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
The FDA Perspective
The FDA Perspective
Ebook (EPUB Format)
CHF 1,175.20
Handbook of Pharmaceutical Manufacturing Formulations
The FDA Perspective
The FDA Perspective
Ebook (PDF Format)
CHF 435.40
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
The FDA Perspective
The FDA Perspective
Ebook (PDF Format)
CHF 1,175.20
Handbook of Pharmaceutical Manufacturing Formulations
The FDA Perspective
The FDA Perspective
Ebook (PDF Format)
CHF 435.40
Handbook of Pharmaceutical Manufacturing Formulations
The FDA Perspective
The FDA Perspective
Ebook (PDF Format)
CHF 435.40
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
The FDA Perspective
The FDA Perspective
Ebook (EPUB Format)
CHF 81.25
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
The FDA Perspective
The FDA Perspective
Ebook (EPUB Format)
CHF 66.35
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
The FDA Perspective
The FDA Perspective
Ebook (EPUB Format)
CHF 81.25
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
The FDA Perspective
The FDA Perspective
Ebook (PDF Format)
CHF 81.25
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
The FDA Perspective
The FDA Perspective
Ebook (EPUB Format)
CHF 81.25
Handbook of Pharmaceutical Manufacturing Formulations
The FDA Perspective
The FDA Perspective
Ebook (PDF Format)
CHF 81.25
Handbook of Pharmaceutical Manufacturing Formulations
The FDA Perspective
The FDA Perspective
Ebook (PDF Format)
CHF 116.10
Bewertungen
Anmelden