Biosimilar Clinical Development : Scientific Considerations and New Methodologies

Barker, Kerry B. (EDT); Menon, Sandeep M. (EDT); D'agostino, Sr. (EDT); Xu, Siyan (EDT); Jin (EDT)

ISBN 10: 0367736527 / ISBN 13: 9780367736521

Published by Routledge, 2020

About this Item

Seller Inventory # 42406532-n

Bibliographic Details

• Title: Biosimilar Clinical Development : Scientific Considerations and New Methodologies
• Publisher: Routledge
• Publication Date: 2020
• Language: English
• ISBN 10: 0367736527
• ISBN 13: 9780367736521
• Binding: Soft cover
• Condition: New

About this title

Synopsis

Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and patient care, and this impact will only grow as our understanding and technologies improve. Written by a team of experienced specialists in clinical development, this book discusses various potential drug development strategies, the design and analysis of pharmacokinetics (PK) studies, and the design and analysis of efficacy studies.

About the Author

Dr. Kerry B. Barker is the Vice-President and Head of Early Oncology Research Statistics at Pfizer, Dr. Sandeep Menon is the Vice-President and Head of Biostatistics Research and Consulting Center at Pfizer , Dr. Ralph D’Agostino is a professor of Mathematics and Statistics at Boston University, Dr. Siyan Xu is a senior principal biostatistician at Novartis and Dr.Bo Jin is the Director of Biostatistics in Early Oncology Research at Pfizer. All have been involved with biosimilars clinical development across all regions of the world.