Code: 44404654

Biosimilarity

Name: Biosimilarity
Brand: Taylor & Francis Ltd
SKU: 44404654
Price: 74.24 EUR
Availability: BackOrder
Author: Niazi
ISBN: 9781032652351

by Niazi, Sarfaraz K. (Therapeutic Proteins International, LLC, Chicago, Illinois, USA)

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 t ... more

Language: English
Binding: Paperback
Number of pages: 436
Publisher: Taylor & Francis Ltd, 2023
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Book synopsis

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

Book details

74.24 €

Full title: Biosimilarity
Subtitle: The FDA Perspective
Author: Niazi, Sarfaraz K. (Therapeutic Proteins International, LLC, Chicago, Illinois, USA)
Language: English
Binding: Paperback
Number of pages: 436
EAN: 9781032652351
ID: 44404654
Publisher: Taylor & Francis Ltd
Weight: 802 g
Dimensions: 254 × 178 mm
Date of publishing: 02. October 2023