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Full Description
Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive coverage on safety monitoring methodologies, covering both global trends and regional initiatives. Pharmacovigilance has traditionally focused on the handling of individual adverse event reports however recently there had been a shift towards aggregate analysis to better understand the scope of product risks.
Written to be accessible not only to statisticians but also to safety scientists with a quantitative interest, this book aims to bridge the gap in knowledge between medical and statistical fields creating a truly multi-disciplinary approach that is very much needed for 21st century safety evaluation.
Contents
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
