Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments (Hardcover)

The Need for Benefit?Risk Assessment and Future Directions
The Need for and Future Directions of Benefit?Risk Evaluations
Neil McAuslane, Larry Liberti, and Stuart Walker

Overview of Benefit?Risk Assessment and Regulatory Environment
Regulatory and Legislative Policy and Science Considerations in the Era of Patient- Centeredness, Big Data, and Value
Tarek Hammad and George Neyarapally

Benefit?Risk Determinations at the FDA Center for Devices and Radiological Health
Telba Irony and Martin Ho

Considerations of Benefit?Risk Assessment Development in Products’ Life Cycle Management
Understanding and Evaluating Uncertainties in the Assessment of Benefit?Risk in Pharmaceutical Drug Development
Qi Jiang, Haijun Ma, Christy Chuang-Stein, Scott Evans, Weili He, George Quartey, John Scott, Shihua Wen, and Ramin Arani

Quantifying Patient Preferences for Regulatory Benefit?Risk Assessments
F. Reed Johnson and Mo Zhou

Choice of Metrics and Other Considerations for Benefit?Risk Analysis in Subgroups
Steven Snapinn and Qi Jiang

Sources of Data to Enable Benefit?Risk Assessment
Christy Chuang-Stein, George Quartey, Weili He, Qi Jiang, Haijun Ma, Jonathan Norton, John Scott, and Jesse Berlin

Benefit?Risk Assessment Methods and Visual Tools
Overview of Benefit?Risk Evaluation Methods: A Spectrum from Qualitative to Quantitative
George Quartey, Chunlei Ke, Christy Chuang-Stein, Weili He, Qi Jiang, Kao-Tai Tsai, Guochen Song, and John Scott

Benefit?Risk Evaluation Using a Framework of Joint Modeling and Joint Evaluations of Multiple Efficacy and Safety Endpoints
Weili He and Bo Fu

Visualization of Benefit?Risk Assessment in Medicinal Products with Real Examples
Shihua Wen, Weili He, Scott Evans, Haijun Ma, Christy Chuang-Stein, Qi Jiang, Xuefeng Li, George Quartey, and Ramin Arani

Benefit?Risk Assessment Case Studies and Lessons Learned
Practical Considerations for Benefit?Risk Assessment and Implementation: Vorapaxar TRA-2°P TIMI 50 Case Study
Weili He, Daniel Bloomfield, Yabing Mai, and Scott Evans

A Quantitative Benefit and Risk Assessment to Determine Optimal Retrieval Time for Inferior Vena Cava Filters in Patients without Pulmonary Embolism
Xuefeng Li, Telba Z. Irony, and Jose Pablo Morales

Benefit?Risk Assessment via Case Studies
Weili He, Qi Jiang, and George Quartey