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Biopharmaceutical Applied Statistics Symposium : Volume 3 Pharmaceutical Applications / / edited by Karl E. Peace, Ding-Geng Chen, Sandeep Menon
| Biopharmaceutical Applied Statistics Symposium : Volume 3 Pharmaceutical Applications / / edited by Karl E. Peace, Ding-Geng Chen, Sandeep Menon |
| Edizione | [1st ed. 2018.] |
| Pubbl/distr/stampa | Singapore : , : Springer Nature Singapore : , : Imprint : Springer, , 2018 |
| Descrizione fisica | 1 online resource (426 pages) |
| Disciplina | 615.10727 |
| Collana | ICSA Book Series in Statistics |
| Soggetto topico |
Biometry
Biostatistics |
| ISBN | 981-10-7820-3 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Part I: Personalized Medicine -- 1 Targeted Learning of Optimal Individualized Treatment Rules under Cost Constraints -- 2 Uses of Mixture Normal Distribution in Genomics and Otherwise -- 3 Personalized Medicine – Design Considerations -- 4 Adaptive Biomarker Subpopulation and Tumor Type Selection in Phase III Oncology Trials -- 5 High Dimensional Data in Genomics -- Part II: Novel Applications -- 6 Synergy or Additivity - The Importance of Defining the Primary Endpoint -- 7 Full Bayesian Adaptive Dose Finding using Toxicity Probability Interval (TPI) -- 8 Alpha-recycling for the Analyses of Primary and Secondary Endpoints of Clinical Trials -- 9 Expanded Interpretations of Results of Carcinogenicity Studies of Pharmaceuticals -- 1 Clinical Trials in Orphan Drug Development -- 11 Mediation Modeling in Randomized Trials with Non-normal Outcome Variables -- 12 Statistical Considerations in Using Images in Clinical Trials -- 13 Interesting Applications over 30 Years of Consulting -- 14 Uncovering Fraud, Misconduct and Other Data Quality Issues in Clinical Trials -- 15 Development and Evaluation of High Dimensional Prognostic Models -- 16 Design and Analysis of Biosimilar Studies. |
| Record Nr. | UNINA-9910300121003321 |
| Singapore : , : Springer Nature Singapore : , : Imprint : Springer, , 2018 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Biopharmaceutical Applied Statistics Symposium : Volume 1 Design of Clinical Trials / / edited by Karl E. Peace, Ding-Geng Chen, Sandeep Menon
| Biopharmaceutical Applied Statistics Symposium : Volume 1 Design of Clinical Trials / / edited by Karl E. Peace, Ding-Geng Chen, Sandeep Menon |
| Edizione | [1st ed. 2018.] |
| Pubbl/distr/stampa | Singapore : , : Springer Nature Singapore : , : Imprint : Springer, , 2018 |
| Descrizione fisica | 1 online resource (XIV, 409 p. 54 illus., 28 illus. in color.) |
| Disciplina | 615.10727 |
| Collana | ICSA Book Series in Statistics |
| Soggetto topico |
Biometry
Biostatistics |
| ISBN | 981-10-7829-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. A Statistical Approach to Clinical Trial Simulations -- 2. Comparison of Statistical Analysis Methods Using Modeling and Simulation for Optimal Protocol Design -- 3. Adaptive Trial Design in Clinical Research -- 4. Best Practices and Recommendations for Trial Simulations Within the Context of Designing Adaptive Clinical Trials -- 5. Designing and Analyzing Recurrent Event Data Trials -- 6. Bayesian Methodologies for Response-Adaptive Allocation -- 7. Addressing High Placebo Response in Neuroscience Clinical Trials -- 8. Phase I Cancer Clinical Trial Design: Single and Combination Agents -- 9. Sample Size and Power for the Mixed Linear Model -- 10. Crossover Designs -- 11. Data monitoring: Structure for Clinical Trials and Sequential Monitoring Procedures -- 12. Design and Data Analysis of Multiregional Clinical Trials (MRCT) – Theory and Practice -- 13. Multiregional Clinical Trials (MRCT) -- 14. Adaptive Group-Sequential Multi-regional Outcome Studies in Vaccines -- 15. Development and validation of Patient-reported Outcomes -- 16. Interim Analysis of Survival Trials: Group Sequential Analyses and Conditional Power. |
| Record Nr. | UNINA-9910300110403321 |
| Singapore : , : Springer Nature Singapore : , : Imprint : Springer, , 2018 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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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 | ||
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Quantitative evaluation of safety in drug development : design, analysis and reporting / / edited by Qi Jiang, Amgen Inc, Thousand Oaks, California, USA; H. Amy Xia, Amgen Inc, Thousand Oaks, California, USA
| Quantitative evaluation of safety in drug development : design, analysis and reporting / / edited by Qi Jiang, Amgen Inc, Thousand Oaks, California, USA; H. Amy Xia, Amgen Inc, Thousand Oaks, California, USA |
| Pubbl/distr/stampa | Boca Raton : , : CRC Press, , [2015] |
| Descrizione fisica | 1 online resource (374 p.) |
| Disciplina |
615.1072/7
615.10727 |
| Collana | Chapman and Hall/CRC Biostatistics Series |
| Soggetto topico | Drug development |
| ISBN |
0-429-08795-0
1-4665-5547-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Contents; Preface; Editors; Contributors; Chapter 1: Incorporating Quantitative Safety Evaluation into Risk Management; Chapter 2: Bayesian Meta-Experimental Design for Evaluating Cardiovascular Risk; Chapter 3: Non-Inferiority Study Design and Analysis for Safety Endpoints; Chapter 4: Program Safety Analysis Plan: An Implementation Guide; Chapter 5: Why a DMC Safety Report Differs from a Safety Section Written at the End of the Trial; Chapter 6: Safety Surveillance and Signal Detection Process; Chapter 7: Bayesian Adaptive Trials for Drug Safety
Chapter 8: Observational Safety Study Design, Analysis, and ReportingChapter 9: Emerging Role of Observational Health-Care Data in Pharmacovigilance; Chapter 10: Roadmap for Causal Inference in Safety Analysis; Chapter 11: Safety Graphics; Chapter 12: Bayesian Network Meta-Analysis for Safety Evaluation; Chapter 13: Regulatory Issues in Meta-Analysis of Safety Data; Chapter 14: Bayesian Applications for Drug Safety Evaluation; Chapter 15: Risk-Benefit Assessment Approaches; Chapter 16: Detecting Safety Signals in Subgroups Chapter 17: Overview of Safety Evaluation and Quantitative Approaches during Preclinical and Early Phases of Drug DevelopmentBack Cover |
| Record Nr. | UNINA-9910787843703321 |
| Boca Raton : , : CRC Press, , [2015] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Statistical aspects of the design and analysis of clinical trials [[electronic resource] /] / Brian S. Everitt, Andrew Pickles
| Statistical aspects of the design and analysis of clinical trials [[electronic resource] /] / Brian S. Everitt, Andrew Pickles |
| Autore | Everitt Brian |
| Edizione | [Rev. ed.] |
| Pubbl/distr/stampa | London, : Imperial College Press |
| Descrizione fisica | 1 online resource (338 p.) |
| Disciplina | 615.10727 |
| Altri autori (Persone) | PicklesAndrew |
| Soggetto topico |
Clinical trials - Statistical methods
Clinical medicine - Research |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-281-86650-4
9786611866501 1-86094-544-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | An introduction to clinical trials -- Treatment allocation, the size of trials and reporting results -- Monitoring trial progress: outcome measures, compliance, dropouts and interim analyses -- Basic analyses of clinical trials, the generalized linear model and the economic evaluation of trials -- Simple approaches to the analysis of longitudinal data from clinical trials -- Multivariate normal regression models for longitudinal data from clinical trials -- Models for non-normal longitudinal data from clinical trials -- Survival analysis -- Bayesian methods longitudinal data -- Meta-analysis. |
| Record Nr. | UNINA-9910450180803321 |
Everitt Brian
|
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| London, : Imperial College Press | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Statistical aspects of the design and analysis of clinical trials [[electronic resource] /] / Brian S. Everitt, Andrew Pickles
| Statistical aspects of the design and analysis of clinical trials [[electronic resource] /] / Brian S. Everitt, Andrew Pickles |
| Autore | Everitt Brian |
| Edizione | [Rev. ed.] |
| Pubbl/distr/stampa | London, : Imperial College Press |
| Descrizione fisica | 1 online resource (338 p.) |
| Disciplina | 615.10727 |
| Altri autori (Persone) | PicklesAndrew |
| Soggetto topico |
Clinical trials - Statistical methods
Clinical medicine - Research |
| ISBN |
1-281-86650-4
9786611866501 1-86094-544-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | An introduction to clinical trials -- Treatment allocation, the size of trials and reporting results -- Monitoring trial progress: outcome measures, compliance, dropouts and interim analyses -- Basic analyses of clinical trials, the generalized linear model and the economic evaluation of trials -- Simple approaches to the analysis of longitudinal data from clinical trials -- Multivariate normal regression models for longitudinal data from clinical trials -- Models for non-normal longitudinal data from clinical trials -- Survival analysis -- Bayesian methods longitudinal data -- Meta-analysis. |
| Record Nr. | UNINA-9910783484203321 |
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Everitt Brian
|
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| London, : Imperial College Press | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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