Download or read book Clinical and Statistical Considerations in Biosimilar Studies written by Kerry B. Barker and published by Chapman and Hall/CRC. This book was released on 2016-06-01 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.