Biosimilar Clinical Development

Scientific Considerations and New Methodologies

By: Kerry B. Barker (Editor), Sandeep M. Menon (Editor), Siyan Xu (Editor), Sr. D'Agostino (Editor), PhD Jin (Editor)

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eText | 25 November 2016 | Edition Number 1

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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.