Authors: Dr. Kavita Nair, Mr. Rohit Sen
ABSTRACT: Pharmaceutical risk-benefit analysis is a cornerstone of decision-making in modern drug development, regulatory approval, and clinical practice. It provides a structured framework for evaluating therapeutic efficacy against potential risks, ensuring that new and existing medications offer more benefits than harm to patients. With advances in pharmacovigilance, statistical modeling, real-world evidence, and patient-centered care, the methodologies for risk-benefit analysis have evolved significantly. This paper examines the conceptual foundations, methodologies, applications, challenges, and future directions of pharmaceutical risk-benefit analysis. It emphasizes the balance between innovation and safety, highlighting how effective frameworks can improve drug regulation, patient outcomes, and healthcare delivery.
KEYWORDS: Risk-Benefit Analysis, Pharmaceuticals, Patient Safety, Drug Efficacy, Regulatory Science
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