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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
| 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 |
| Pubbl/distr/stampa | Boca Raton : , : Taylor & Francis, , [2017] |
| Descrizione fisica | 1 online resource (269 pages) |
| Disciplina | 615.1/9 |
| Collana | Chapman & Hall/CRC Biostatistics Series |
| Soggetto topico |
Biologicals
Drug development - Methodology |
| ISBN |
1-315-37326-2
1-315-35590-6 1-4822-3170-0 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| 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. |
| Record Nr. | UNINA-9910153182903321 |
| Boca Raton : , : Taylor & Francis, , [2017] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Clinical and statistical considerations in personalized medicine / / edited by Claudio Carini, Pfizer, Cambridge, Massachusetts, USA, Sandeep M. Menon, Pfizer, Cambridge, Massachusetts, USA, Mark Chang, AMAG Pharmaceuticals, Incorporated Waltham, Massach
| Clinical and statistical considerations in personalized medicine / / edited by Claudio Carini, Pfizer, Cambridge, Massachusetts, USA, Sandeep M. Menon, Pfizer, Cambridge, Massachusetts, USA, Mark Chang, AMAG Pharmaceuticals, Incorporated Waltham, Massach |
| Pubbl/distr/stampa | Boca Raton : , : CRC Press, , [2014] |
| Descrizione fisica | 1 online resource (368 p.) |
| Disciplina |
615.7072/7
615.70727 |
| Collana | Chapman and Hall/CRC Biostatistics Series |
| Soggetto topico |
Pharmacogenetics - Mathematical models
Pharmacogenetics - Statistical methods Pharmacogenomics - Mathematical models Pharmacogenomics - Statistical methods |
| ISBN |
0-429-16933-7
1-4665-9387-3 |
| Classificazione | MAT029000MED045000MED071000 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Contents; Preface; Editors; Contributors; Chapter 1: Biomarkers for Drug Development: The Time Is Now!; Chapter 2: RNAi Screens: Triumphs and Tribulations; Chapter 3: Current Advances in Epigenetics; Chapter 4: Biomarkers and Precision Medicine: The Case of Rare Diseases; Chapter 5: Biomarker-Informed Adaptive Design; Chapter 6: Fitting the Dose: Adaptive Staggered Dose Design; Chapter 7: Evidence-Based Adaptive Statistical Decision and Design Strategies for; Chapter 8: Biomarker Identification in Clinical Trials; Chapter 9: Multiplicity in Pharmacogenomics
Chapter 10: Patient-Reported Outcomes in Personalized MedicineChapter 11: Regulatory Issues in Use of Biomarkers in Drug Development; Back Cover |
| Record Nr. | UNINA-9910789244103321 |
| Boca Raton : , : CRC Press, , [2014] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Clinical and statistical considerations in personalized medicine / / edited by Claudio Carini, Pfizer, Cambridge, Massachusetts, USA, Sandeep M. Menon, Pfizer, Cambridge, Massachusetts, USA, Mark Chang, AMAG Pharmaceuticals, Incorporated Waltham, Massach
| Clinical and statistical considerations in personalized medicine / / edited by Claudio Carini, Pfizer, Cambridge, Massachusetts, USA, Sandeep M. Menon, Pfizer, Cambridge, Massachusetts, USA, Mark Chang, AMAG Pharmaceuticals, Incorporated Waltham, Massach |
| Pubbl/distr/stampa | Boca Raton : , : CRC Press, , [2014] |
| Descrizione fisica | 1 online resource (368 p.) |
| Disciplina |
615.7072/7
615.70727 |
| Collana | Chapman and Hall/CRC Biostatistics Series |
| Soggetto topico |
Pharmacogenetics - Mathematical models
Pharmacogenetics - Statistical methods Pharmacogenomics - Mathematical models Pharmacogenomics - Statistical methods |
| ISBN |
0-429-16933-7
1-4665-9387-3 |
| Classificazione | MAT029000MED045000MED071000 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Contents; Preface; Editors; Contributors; Chapter 1: Biomarkers for Drug Development: The Time Is Now!; Chapter 2: RNAi Screens: Triumphs and Tribulations; Chapter 3: Current Advances in Epigenetics; Chapter 4: Biomarkers and Precision Medicine: The Case of Rare Diseases; Chapter 5: Biomarker-Informed Adaptive Design; Chapter 6: Fitting the Dose: Adaptive Staggered Dose Design; Chapter 7: Evidence-Based Adaptive Statistical Decision and Design Strategies for; Chapter 8: Biomarker Identification in Clinical Trials; Chapter 9: Multiplicity in Pharmacogenomics
Chapter 10: Patient-Reported Outcomes in Personalized MedicineChapter 11: Regulatory Issues in Use of Biomarkers in Drug Development; Back Cover |
| Record Nr. | UNINA-9910806250903321 |
| Boca Raton : , : CRC Press, , [2014] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||