This book 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.
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.
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"This is an amazing book for anyone working in the clinical research industry and does not require at all extensive knowledge of statistics or prior exposure to statistics at all. In fact, I would say that the target audience is broader than just statisticians but including instead everyone working in the clinical research industry involved in study planning, analysis and/or reporting."
- David Manteigas, ISCB News, September 2022.
"Overall, this book provides thorough background andknowledge about clinical considerations and regulatory policies, as well as a comprehensive review of frequently used safety-specific statistical methods with clear and thoughtful explanations. . . Therefore, I strongly recommend this book to all who eithe ralready work on clinical studies or who are new to the area and are interested in clinical trial planning and analyses."
- Huan Wang, The American Statistician, January 2023.
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