Structured Benefit-Risk Assessments: An Illustrative Case Study of Paracetamol.

This paper aims to provide an overview of the steps in developing a structured benefit-risk assessment, along with simple, salient, and timely example its implications. Using time-tested, non-prescription drug paracetamol (a.k.a. acetaminophen) as example, we demonstrate fundamental role well-structured assessment may play clarifying safety profile even well-established medicinal products. The balance performed by manufacturers others involved keeping drugs on market is integral non-stop continuum throughout product’s lifecycle. provides further reassurance that, world grapples new diseases, pharmacovigilance systems robust tools such assessments can evolve adapt essential preventive mitigative strategies. All these examples practices contain through-line consideration for protection public health, foundational cornerstone practice. While wealth information be explored each aspect presented topics, authors aim give those readers only minimal background appreciation value assessments.