Quantitative Drug Safety and Benefit Risk Evaluation
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Quantitative Drug Safety and Benefit Risk Evaluation
Practical and Cross-Disciplinary Approaches
Munsaka, Melvin; Wang, William; Li, Judy; Buchanan, James
Taylor & Francis Ltd
12/2021
382
Dura
Inglês
9781138594067
15 a 20 dias
680
Descrição não disponível.
1 The Emergence of Aggregate Safety Assessment Across the Regulatory Landscape 2 Aggregate Safety Assessment Planning in Clinical Development 3 Safety Signaling and Causal Evaluation 4 Safety Monitoring through External Committees 5 An Overview on Statistical Methodologies for Safety Monitoring and Benefit-Risk Assessment 6 Quantitative Methods for Blinded Safety Monitoring 7 Bayesian Safety Methodology 8 Likelihood-Based Methods for Safety Monitoring 9 Meta-Analysis for Drug Safety Assessment 10 Design consideration for pragmatic trials with insight from cardiovascular outcome trials 11 Post-market Safety Assessment Using Observational Studies and the FDA Sentinel System 12 Analysis Considerations for Real-World Evidence and Clinical Trials Related to Safety 13 Trends and Recent Progress in Benefit-Risk Assessment Planning for Medical Products and Devices 14 Estimands in Safety and Benefit Risk Evaluation 15 Visual Analytics for Safety and Benefit Risk Evaluation
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
BCPNN.;FDA;MedDRA Dictionary;clinical traits;Data Monitoring Committee;drug safety;MedDRA Prefer Term;Multi-item Gamma Poisson Shrinker;MedDRA Version;Benefit Risk Assessment;Benefit Risk Evaluation;FDA Guidance;FDA Adverse Event Report System;Identified Safety Signal;Key Efficacy Endpoints;Exposure Time;Ich E9;Prior Data Conflict;Sequential Probability Ratio Test;Good Pharmacovigilance Practices;FDA Draft Guidance;MedDRA System Organ Class;Standardize MedDRA Query;Pro Endpoint;Ich E6;Safety Monitoring;Benefit Risk Balance;Signal Detection
1 The Emergence of Aggregate Safety Assessment Across the Regulatory Landscape 2 Aggregate Safety Assessment Planning in Clinical Development 3 Safety Signaling and Causal Evaluation 4 Safety Monitoring through External Committees 5 An Overview on Statistical Methodologies for Safety Monitoring and Benefit-Risk Assessment 6 Quantitative Methods for Blinded Safety Monitoring 7 Bayesian Safety Methodology 8 Likelihood-Based Methods for Safety Monitoring 9 Meta-Analysis for Drug Safety Assessment 10 Design consideration for pragmatic trials with insight from cardiovascular outcome trials 11 Post-market Safety Assessment Using Observational Studies and the FDA Sentinel System 12 Analysis Considerations for Real-World Evidence and Clinical Trials Related to Safety 13 Trends and Recent Progress in Benefit-Risk Assessment Planning for Medical Products and Devices 14 Estimands in Safety and Benefit Risk Evaluation 15 Visual Analytics for Safety and Benefit Risk Evaluation
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
BCPNN.;FDA;MedDRA Dictionary;clinical traits;Data Monitoring Committee;drug safety;MedDRA Prefer Term;Multi-item Gamma Poisson Shrinker;MedDRA Version;Benefit Risk Assessment;Benefit Risk Evaluation;FDA Guidance;FDA Adverse Event Report System;Identified Safety Signal;Key Efficacy Endpoints;Exposure Time;Ich E9;Prior Data Conflict;Sequential Probability Ratio Test;Good Pharmacovigilance Practices;FDA Draft Guidance;MedDRA System Organ Class;Standardize MedDRA Query;Pro Endpoint;Ich E6;Safety Monitoring;Benefit Risk Balance;Signal Detection
