Biosimilarity: The FDA Perspective - Couverture rigide

Niazi, Sarfaraz K.

Couverture rigide

ISBN 10 : 1498750397 ISBN 13 : 9781498750394

Editeur : CRC Press Inc, 2018

A propos du livre

Présentation de l'éditeur :

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

Biographie de l'auteur :

Sarfaraz K. Niazi Ph.D,  is Adjunct Professor at the faculty of University of Houston as well Chairman and President of Therapeutic Proteins Inc.

À propos de cette édition

• Éditeur: CRC Press Inc
• Date d'édition: 2018
• ISBN 10: 1498750397
• ISBN 13: 9781498750394
• Reliure: Relié
• Nombre de pages: 398