Biosimilar clinical development: scientific considerations and new methodologies
by Barker, Kerry B. Bo Jin D'Agostino, Ralph B. Menon, Sandeep M. Xu, Siyan
Title Statements
- Full title :Biosimilar clinical development : scientific considerations and new methodologies / editors, Kerry B. Barker [and four others].
Edition Statements
- Publication Date:©2017
Publication Statements
- Publisher(s):CRC Press
- Place of Publication:Boca Raton
- Language:eng
- Publication Date:©2017
The Physical Object
- Description:1 online resource
Edition Identifiers
- ISBN:9781482231700, 1482231700, 9781315373263, 1315373262
- oclc:ocn964526508
- LC Classification:RS162
- Dewey Decimal:615.1/9
Table of Contents
1. Biosimilars for drug development : the time is now! / Bo Jin, Sandeep M. Menon, Kerry B. Barker, and Ralph B. D'Agostino -- 2. From isolation to integration : a systems biology approach for the discovery of therapeutic targets and biomarkers / Attila Seyhan and Claudio Carini -- 3. Immunogenicity of biological products : current perspectives and future implications / Candida Fratazzi, Attila Seyhan, and Claudio Carini -- 4. Interchangeability between biosimilar and innovator drug products / Bo Jin, Sandeep M. Menon, Kerry B. Barker, and Steven Ye Hua -- 5. Bridging a new biological product with its reference product / Jianfun (David) Li and Jin Xu -- 6. Accounting for covariate effect to show noninferiority in biosimilars / Siyan Xu, Kerry B. Barker, Sandeep M. Menon, and Ralph B. D'Agostino -- 7. Novel method in inference of equivalence in biosimilars / Siyan Xu, Steven Ye Hua, Ronald Menton, Kerry B. Barker, Sandeep M. Menon, and Ralph B. D'Agostino -- 8. Multiplicity adjustments in testing for bioequivalence / Steven Ye Hua, Siyan Xu, and Ralph B. D'Agostino -- 9. Bayesian methods to assess bioequivalence and biosimilarity with case studies / Steven Ye Hua, Siyan Xu, Kerry B…
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