Benefit–risk evaluation: the past present and future

摘要

In the last two decades there has been a shift in the approach to evaluating the benefit–risk (BR) profiles of medicinal products from an unstructured, subjective, and inconsistent, to a more structured and objective, process. This article describes that shift from a historical perspective; the past, the present, and the future, and highlights key events that played critical roles in changing the field.