| Description |
1 online resource (269 pages) |
| Series |
Chapman & Hall/CRC Biostatistics Series |
|
Chapman & Hall/CRC biostatistics series.
|
| Contents |
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 Biosimilars8. 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 |
| Notes |
Print version record |
| Subject |
Drug development -- Methodology
|
|
Biologicals.
|
|
Biological products.
|
|
Biological Factors
|
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Biological Products
|
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Biological products
|
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Biologicals
|
| Form |
Electronic book
|
| Author |
Menon, Sandeep M
|
|
D'Agostino, Sr., Ralph B
|
|
Xu, Siyan
|
|
Jin, PhD, Bo
|
| ISBN |
9781315355900 |
|
1315355906 |
|
