Biosimilar Clinical Development: Scientific Considerations and New Methodologies

1st Edition

Kerry B. Barker, Sandeep M. Menon, Ralph B. D'Agostino, Sr., Siyan Xu, Bo Jin, PhD

Chapman and Hall/CRC
Published January 17, 2017
Reference - 248 Pages - 31 Color Illustrations
ISBN 9781482231694 - CAT# K22734
Series: Chapman & Hall/CRC Biostatistics Series

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Summary

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.

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