Role and place of causality assessment

Publisher Website
Google Scholar
Abstract
For biological reasons a drug has either caused or contributed to the development of an adverse reaction or it has not. All intermediary evaluations like possible, probable, etc. are only approximations of the unknown truth. Three practical approaches to assessment are possible — unstructured, based solely on knowledge and experience; semi‐structured, based on certain descriptive criteria; and standardized, based on an operational logic. Nowadays, causality assessment is understood as one of the signaling and sorting parameters and the many drug regulatory agencies assess causality, although rarely using a standardized assessment. The globalization of drug monitoring efforts speaks for a wider acceptance of one method as it would help to understand better how and why a particular assessment was reached.

This publication has 7 references indexed in Scilit: