Volume 30, Issue 3 - Medical decision making and health technology assessment
Regulatory Matters
Authors: Jennifer Morris, Elise Eller
Abstract
Early in my regulatory medical writing career, I wrote several protocols in the cardiology therapeutic area. I was introduced to the cardiac biomarkers troponin I and N-terminal prohormone brain natriuretic peptide (NTproBNP), which are indicators of cardiac injury and cardiac dysfunction, respectively. Before that, I had done a lot of work in oncology, and I was accustomed to biomarkers such as HER2 that can be used to define a patient population for a given treatment.
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