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OverviewSummary: 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 Full Product DetailsAuthor: Sarfaraz K. Niazi (Therapeutic Proteins International, LLC, USA)Publisher: Taylor & Francis Ltd Imprint: CRC Press Weight: 1.000kg ISBN: 9781032652351ISBN 10: 1032652357 Pages: 436 Publication Date: 02 October 2023 Audience: College/higher education , Professional and scholarly , Postgraduate, Research & Scholarly , Professional & Vocational Format: Paperback Publisher's Status: Active Availability: In Print  This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us. Table of ContentsCurrent Status of Biosimilar Biological Products. The FDA Position. Biosimilarity Tetrahedron. Analytical and Functionality Similarity. Non-clinical Assessment. Clinical Pharmacology Assessment. Clinical Studies. Interchangeability Status. Comprehensive PresentationReviewsAuthor InformationSarfaraz K. Niazi Ph.D, is Adjunct Professor at the faculty of University of Houston as well Chairman and President of Therapeutic Proteins Inc. Tab Content 6Author Website:Countries AvailableAll regions |
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