A systematic, concept-based method of developing the exposure measure for drug safety and effectiveness studies.
Lisa K KuramotoBoris G SobolevJan RosnerPenelope M A BrasherLaurent AzoulayJacquelyn J CraggPublished in: Pharmacoepidemiology and drug safety (2021)
The proposed approach links exposure specifications to four major concepts in drug safety and effectiveness studies. Formulating subject-matter knowledge about these major concepts provides an avenue to develop the rationale and specifications for the exposure measure.