Biosimilar Clinical Development: Scientific Considerations and New Methodologies

ISBN-13: 9781482231694 / Angielski / Twarda / 2016 / 248 str.

Opis

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.

Spis treści

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.