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Titolo: |
Biosimilar clinical development : scientific considerations and new methodologies / / edited by Kerry B. Barker, Pfizer, Cambridge, Massachusetts, USA, Sandeep M. Menon, Pfizer, Cambridge, Massachusetts, USA, Ralph B. D'Agostino, Sr., Boston Uni
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Pubblicazione: | Boca Raton : , : Taylor & Francis, , [2017] |
©2017 | |
Descrizione fisica: | 1 online resource (269 pages) |
Disciplina: | 615.1/9 |
Soggetto topico: | Biologicals |
Drug development - Methodology | |
Persona (resp. second.): | BarkerKerry B. |
MenonSandeep M. | |
D'AgostinoRalph B. | |
XuSiyan | |
JinBo | |
Note generali: | A Chapman and Hall book--title page. |
Nota di bibliografia: | Includes bibliographical references at the end of each chapters and index. |
Nota di contenuto: | 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 /Jianjun (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. Barker, Shan Mei Liao, and Shujie Li -- 10. Average inferiority measure and standardized margins to address the issues in biosimilar trials / Gang Li and Weichung Joe Shih -- 11. Bayesian methods for design and analysis of noninferiority trials / Mani Lakshminarayanan and Fanni Natanegara. |
Titolo autorizzato: | Biosimilar clinical development ![]() |
ISBN: | 1-315-37326-2 |
1-315-35590-6 | |
1-4822-3170-0 | |
Formato: | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione: | Inglese |
Record Nr.: | 9910153182903321 |
Lo trovi qui: | Univ. Federico II |
Opac: | Controlla la disponibilità qui |