1st Edition
Biosimilar Clinical Development: Scientific Considerations and New Methodologies
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.
Biosimilars for Drug Development. Regulatory Requirements on Biosimilars. System Biology in the Context of Biosimilars. Clinical Considerations on Biosimilars. Large Molecules Complete Molecular Confidence (CMC) Development Strategy. Immunogenicity. Interchangeability. Bridging a New Biologic to Its Reference Biologic. How to Account Covariate Effect to Show Non-Inferiority in Biosimilars. Novel Method in Inference of Equivalence in Biosimilars. Multiplicity Adjustment in Equivalence Using Two One-Sided Tests. Bayesian Methods in Biosimilar Studies.
Biography
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.
"Thus, the book Biosimilar Clinical Development contains five chapters discussing general issues involving biosimilars. The remaining six chapters present statistical methods, many of which are new, and their applications in bioequivalence and biosimilarity studies; they are really research papers. . . It will appeal to readers interested in biosimilars and especially in their statistical assessments."
~Laszlo Endrenyi, University of Toronto“The book is edited by a team of renowned experts from both statistics and biosimilar clinical development. It contains 11 chapters, covering not only statistical issues but also pre-clinical and clinical development issues not regularly discussed on this kind of book, as well as references to regulatory considerations of upmost importance for statisticians working in the strongly regulated environment of clinical development . . . I strongly recommend the reading of this book. In my opinion, the book should be a must-have reading for professionals who work regularly with biosimilars and want to have an overview of state-of-the art methods for 'hot-topics' in the analysis and planning of clinical trials for this purpose.”
~David Manteigas
