Quantitative Drug Safety and Benefit Risk Evaluation

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 21^st century safety evaluation.

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Description

Quantitative Drug Safety and Benefit Risk Evaluation: Practical and Cross-Disciplinary Approaches (Chapman & Hall/CRC Biostatistics Series)

By William Wang (Editor), Melvin Munsaka (Editor), James Buchanan (Editor), Judy Li (Editor)

Comprehensive Coverage of Safety Monitoring: Focuses on global trends and regional initiatives in pharmacovigilance and safety monitoring.
Shift from Adverse Event Reports to Aggregate Analysis: Highlights the recent transition towards aggregate data analysis for a better understanding of product risks.
Target Audience: Accessible to both statisticians and safety scientists with a quantitative interest, promoting a multidisciplinary approach.
Bridging Medical and Statistical Fields: Aims to close the knowledge gap between medical and statistical disciplines, fostering collaboration in safety evaluation.
21st Century Approach: Emphasizes the need for innovative, modern methodologies in ongoing benefit-risk evaluation for drug safety.

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