Biosimilarity: The FDA Perspective - Hardcover
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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About the Author:
Sarfaraz K. Niazi Ph.D, is Adjunct Professor at the faculty of University of Houston as well Chairman and President of Therapeutic Proteins Inc.
"About this title" may belong to another edition of this title.
- PublisherCRC Press
- Publication date2018
- ISBN 10 1498750397
- ISBN 13 9781498750394
- BindingHardcover
- Edition number1
- Number of pages398
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BIOSIMILARITY
Published by
CRC Press
(2018)
ISBN 10: 1498750397
ISBN 13: 9781498750394
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Hardcover
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Book Description Gebunden. Condition: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Sarfaraz K. Niazi Ph.D, is Adjunct Professor at the faculty of University of Houston as well Chairman and President of Therapeutic Proteins Inc.First comprehensive analysis based on new guidelines and approval packages of . Seller Inventory # 596130894
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