Biosimilar Clinical Development: Scientific Considerations and New Methodologies

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

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

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Features

  • Represents one of the first books to deal with both statistical and clinical issues in the field
  • Covers relevant industry challenges surrounding biosimilar studies
  • Addresses specific questions on how to make biologic products more affordable to patients

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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