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Quantitative Drug Safety and Benefit Risk Evaluation

Quantitative Drug Safety and Benefit Risk Evaluation

Pages: 402

Publisher: Chapman & Hall

Year of Publication: 2024

Author(s) : William Wang, Melvin Munsaka, James Buchanan, Judy Li

Book 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.

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