aggregate safety reports
Aggregate Safety Reports (ASRs) are comprehensive documents prepared by pharmaceutical companies to evaluate and communicate the safety profile of a drug over a specific period. Unlike individual case safety reports (ICSRs), ASRs analyze safety data collectively, offering insights into trends, risks, and the benefit-risk balance of a product. Common types include Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs). These reports are crucial for regulatory compliance, ensuring ongoing patient safety, and guiding informed decision-making in drug development and post-marketing surveillance.