Biosimilar Clinical Development

Biosimilar Clinical Development

by Barker, Kerry B.

Type Book
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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…

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Title Statements

  • Full title :Biosimilar Clinical Development

Summary

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

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Edition Statements

  • Publication Date:2016

Publication Statements

  • Publisher(s):CRC Press
  • Place of Publication:Boca Raton
  • Language:eng
  • Publication Date:2016

Notes

IMD-Felder maschinell generiert

The Physical Object

  • Description:1 Online-Ressource (269 Seiten)

Edition Identifiers

  • ISBN:9781315355900, 1315355906, 9781482231694, 1482231697
  • oclc:on1020854202
  • LC Classification:RS162.B5612 2017

Writers

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

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