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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| 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 |
Serie:
Chapman & Hall/CRC biostatistics series.