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] | ||
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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 |
Edizione | [1st ed.] |
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-9910829143003321 |
Boca Raton : , : CRC Press, , [2015] | ||
![]() | ||
Lo trovi qui: Univ. Federico II | ||
|