Biosimilar Clinical Development: Scientific Considerations and New Methodologies
Biosimilar Clinical Development: Scientific Considerations and New Methodologies
CRC Press | English | March 23, 2017 | ISBN-10: 1482231697 | 262 pages | PDF | 5.58 mb
CRC Press | English | March 23, 2017 | ISBN-10: 1482231697 | 262 pages | PDF | 5.58 mb
By Kerry B. Barker, Sandeep M. Menon, Ralph B. D'Agostino, Sr., Siyan Xu, Bo Jin, PhD
Represents one of the first books to deal with both statistical and clinical issues in the field
Covers relevant industry challenges surrounding biosimilar studies
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.
Editor(s) Bio
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.