This book provides a comprehensive and state-of-the-art overview of benefit-risk assessment methods in drug development. Unlike other books which focus mainly on qualitative benefit-risk assessments, this book looks at both quantitative and qualitative methods, spanning from drug development to lifecycle management. The text covers design, analysis, and reporting issues for both clinical trials and observational studies, and looks at benefit-risk assessments from various perspectives, including regulatory agencies, sponsors, industry, academia, and patients.
Qi Jiang, Ph.D, is executive director of global biostatistics science at Amgen.
Weili He, Ph.D, is affiliated with late development statistics at Merck & Co., Inc.
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