Quantitative Drug Safety and Benefit Risk Evaluation

<p><b><i>Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation </i></b>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.</p><p>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 21^st century safety evaluation.</p>