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.

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Yes, you can access Biosimilar Clinical Development: Scientific Considerations and New Methodologies by Kerry B. Barker, Sandeep M. Menon, Sr. D'Agostino, Siyan Xu, PhD Jin, Kerry B. Barker,Sandeep M. Menon,Ralph B. D'Agostino, Sr.,Siyan Xu,Bo Jin, PhD, Kerry B. Barker, Sandeep M. Menon, Ralph B. D'Agostino, Sr., Siyan Xu, Bo Jin, PhD in PDF and/or ePUB format, as well as other popular books in Mathematics & Probability & Statistics. We have over one million books available in our catalogue for you to explore.

Information

Publisher

Year

Print ISBN

eBook ISBN

Edition

Topic

Mathematics

Subtopic

Probability & Statistics

Index

Mathematics

Cover
Half Title
Title Page
Copyright Page
Contents
Preface
Editors
Contributors
1. Biosimilars for Drug Development: The Time Is Now!
2. From Isolation to Integration: A Systems Biology Approach for the Discovery of Therapeutic Targets and Biomarkers
3. Immunogenicity of Biological Products: Current Perspectives and Future Implications
4. Interchangeability between Biosimilar and Innovator Drug Products
5. Bridging a New Biological Product with Its Reference Product
6. Accounting for Covariate Effect to Show Noninferiority Biosimilars
7. Novel Method in Inference of Equivalence in Biosimilars
8. Multiplicity Adjustments in Testing for Bioequivalence
9. Bayesian Methods to Assess Bioequivalence and Biosimilarity with Case Studies
10. Average Inferiority Measure and Standardized Margins to Address the Issues in Biosimilar Trials
11. Bayesian Methods for Design and Analysis of Noninferiority Trials
Index

About this book

Frequently asked questions

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Table of contents