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Biosimilar Clinical Development: Scientific Considerations and New Methodologies

Kerry B. Barker (Redaktør) ; Sandeep M. Menon (Redaktør) ; Sr. D'Agostino (Redaktør) ; Siyan Xu (Redaktør) ; PhD Jin (Redaktør)

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. Les mer
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Paperback
Legg i
Paperback
Legg i
Vår pris: 725,-

(Paperback) Fri frakt!
Leveringstid: Sendes innen 21 dager
På grunn av Brexit-tilpasninger og tiltak for å begrense covid-19 kan det dessverre oppstå forsinket levering.

Om boka

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.

Fakta

Innholdsfortegnelse

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.

Om forfatteren

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.