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MORE ABOUT THIS BOOK
Main description:
Covers four pillars of safety statistics: cross-disciplinary scientific engagement, effective and efficient operational process, visual analytics, and intelligent data architecture
Links safety monitoring to benefit risk evaluation
Presents an emerging topic that links to ICH E19 and TransCelerate safety efforts
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
PRODUCT DETAILS
Publisher: Taylor & Francis (CRC Press)
Publication date: December, 2021
Pages: 408
Weight: 680g
Availability: Available
Subcategories: Epidemiology, General Issues, Pharmacology