ABSTRACT
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.
TABLE OF CONTENTS
part A|97 pages
Regulatory Landscape and Interdisciplinary Collaboration in Safety Evaluation
part B|114 pages
Statistical Methodologies for Safety Monitoring
part C|70 pages
Design and Analysis Considerations in Randomized Controlled Trials and Real-World Evidence for Safety Decision-Making
part D|91 pages
Safety/Benefit-Risk Evaluation and Visualization