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Design and Analysis of Subgroups with Biopharmaceutical Applications [[electronic resource] /] / edited by Naitee Ting, Joseph C. Cappelleri, Shuyen Ho, (Din) Ding-Geng Chen
| Design and Analysis of Subgroups with Biopharmaceutical Applications [[electronic resource] /] / edited by Naitee Ting, Joseph C. Cappelleri, Shuyen Ho, (Din) Ding-Geng Chen |
| Edizione | [1st ed. 2020.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2020 |
| Descrizione fisica | 1 online resource (404 pages) |
| Disciplina | 615.10727 |
| Collana | Emerging Topics in Statistics and Biostatistics |
| Soggetto topico |
Statistics
Biostatistics Pharmaceutical technology Statistics for Life Sciences, Medicine, Health Sciences Pharmaceutical Sciences/Technology |
| ISBN | 3-030-40105-7 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. Data-driven and Confirmatory Subgroup Analysis in Clinical Trials -- 2. Subgroup Analysis – A View from Industry -- 3. Biomarker-Targeted Confirmatory Trials -- 4. Considerations on Subgroup Analysis in Design and Analysis of Multi-Regional Clinical Trials -- 5. Practical Subgroup Identification Strategies in Late-stage Clinical Trials -- 6. Exploratory Subgroup Identification for Biopharmaceutical Development -- 7. Logical Inference on Treatment Efficacy When Subgroup Exists -- 8. The GUIDE Approach to Subgroup Identification and Inference -- 9. Use of the VG (Virtual Twins Combined with GUIDE) Method in the Development of Precision Medicines -- 10. Subgroups Identification for Tailored Therapies: a System of Methods, a Framework for Consistent Methodology Evaluation, and an Integrated Learn-and-confirm Approach -- 11. Developing and Validating Predictive Classifiers in Randomized Clinical Trials -- 12. Issues Related to Subgroup Analysis -- 13. Subgroup Analysis with Partial Linear Model -- 14. Subgroup Analysis in the 21st Century -- 15. Power of Statistical Tests for Subgroup Analysis in Meta-Analysis -- 16. Heterogeneity and Subgroup Analysis in Network Meta-Analysis. |
| Record Nr. | UNISA-996418272103316 |
| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2020 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
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Design and Analysis of Subgroups with Biopharmaceutical Applications / / edited by Naitee Ting, Joseph C. Cappelleri, Shuyen Ho, (Din) Ding-Geng Chen
| Design and Analysis of Subgroups with Biopharmaceutical Applications / / edited by Naitee Ting, Joseph C. Cappelleri, Shuyen Ho, (Din) Ding-Geng Chen |
| Edizione | [1st ed. 2020.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2020 |
| Descrizione fisica | 1 online resource (404 pages) |
| Disciplina | 615.10727 |
| Collana | Emerging Topics in Statistics and Biostatistics |
| Soggetto topico |
Biometry
Pharmaceutical chemistry Biostatistics Pharmaceutics |
| ISBN | 3-030-40105-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. Data-driven and Confirmatory Subgroup Analysis in Clinical Trials -- 2. Subgroup Analysis – A View from Industry -- 3. Biomarker-Targeted Confirmatory Trials -- 4. Considerations on Subgroup Analysis in Design and Analysis of Multi-Regional Clinical Trials -- 5. Practical Subgroup Identification Strategies in Late-stage Clinical Trials -- 6. Exploratory Subgroup Identification for Biopharmaceutical Development -- 7. Logical Inference on Treatment Efficacy When Subgroup Exists -- 8. The GUIDE Approach to Subgroup Identification and Inference -- 9. Use of the VG (Virtual Twins Combined with GUIDE) Method in the Development of Precision Medicines -- 10. Subgroups Identification for Tailored Therapies: a System of Methods, a Framework for Consistent Methodology Evaluation, and an Integrated Learn-and-confirm Approach -- 11. Developing and Validating Predictive Classifiers in Randomized Clinical Trials -- 12. Issues Related to Subgroup Analysis -- 13. Subgroup Analysis with Partial Linear Model -- 14. Subgroup Analysis in the 21st Century -- 15. Power of Statistical Tests for Subgroup Analysis in Meta-Analysis -- 16. Heterogeneity and Subgroup Analysis in Network Meta-Analysis. |
| Record Nr. | UNINA-9910484444203321 |
| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2020 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Phase II Clinical Development of New Drugs / / by Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri
| Phase II Clinical Development of New Drugs / / by Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri |
| Autore | Ting Naitee |
| Edizione | [1st ed. 2017.] |
| Pubbl/distr/stampa | Singapore : , : Springer Singapore : , : Imprint : Springer, , 2017 |
| Descrizione fisica | 1 online resource (XVII, 241 p. 25 illus., 17 illus. in color.) |
| Disciplina | 615.19 |
| Collana | ICSA Book Series in Statistics |
| Soggetto topico |
Statistics
Pharmaceutical technology Management Statistics for Life Sciences, Medicine, Health Sciences Pharmaceutical Sciences/Technology |
| ISBN | 981-10-4194-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Chapter 1 Introduction -- Chapter 2 Concept of Alpha -- Chapter 3 Confirmation and Exploration -- Chapter 4 Design a Proof of Concept (PoC) Trial -- Chapter 5 Design of Dose-Ranging Trials -- Chapter 6 Combining PoC and Dose Ranging Trials -- Chapter 7 Risks of Inconclusiveness -- Chapter 8 Analysis of a PoC Study -- Chapter 9 Data Analysis for Dose-Ranging Trials with Continuous Outcome -- Chapter 10 Data Analysis of Dose-Ranging Trials for Binary Outcomes -- Chapter 11 Bayesian Methods -- Chapter 12 Overview of Phase III Clinical Trials. |
| Record Nr. | UNINA-9910254273803321 |
Ting Naitee
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| Singapore : , : Springer Singapore : , : Imprint : Springer, , 2017 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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