Biosimilar Clinical Development: Scientific Considerations and New Methodologies

Kerry B. Barker, Sandeep M. Menon, Sr. D'Agostino Ralph B., Siyan Xu, PhD Jin Bo (Herausgeber)

Buch | Hardcover

248 Seiten

2017
Chapman & Hall/CRC (Verlag)
978-1-4822-3169-4 (ISBN)

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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.

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.

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.

Reihe/Serie	Chapman & Hall/CRC Biostatistics Series
Zusatzinfo	31 Illustrations, color
Sprache	englisch
Maße	156 x 234 mm
Gewicht	612 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
Themenwelt	Studium ► Querschnittsbereiche ► Epidemiologie / Med. Biometrie
ISBN-10	1-4822-3169-7 / 1482231697
ISBN-13	978-1-4822-3169-4 / 9781482231694
Zustand	Neuware