About this document
Benefit-Risk Evaluation Evolution by Dhani Rinaldi Maulana is a document available to read on EtoBox.
The article discusses the evolution of benefit-risk (BR) evaluation of medicinal products over the past two decades, highlighting a shift from subjective assessments to more structured and objective methodologies. It outlines key frameworks such as BRAT and PrOACT–URL, which facilitate systematic BR evaluations, and emphasizes the importance of incorporating preference weights from various stakeholders, including patients. The document also reviews initiatives by regulatory agencies like the FDA and EMA to
- Author
- Dhani Rinaldi Maulana
- Language
- EN