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

General

Imprint:	Productivity Press
Country of origin:	United States
Release date:	July 2018
Authors:	Sarfaraz K. Niazi
Dimensions:	254 x 178 x 29mm (L x W x T)
Format:	Hardcover
Pages:	398
ISBN-13:	978-1-4987-5039-4
Categories:	Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
LSN:	1-4987-5039-7
Barcode:	9781498750394

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