ABSTRACT

Pharmacodynamic (PD) biomarkers need to be explored both longitudinally as well as for a particular time point for treatment effect. Usually, the marker is measured both at the start of the subject’s participation in clinical trial and at least at one time point after commencing treatment. The biomarkers could be tissue or blood-based, or from cerebrospinal fluid, urine, or any other biological samples collected from the patient. The biomarkers are not only studied by themselves under treatment and over time, but also their correlation with the end clinical outcome is often reported as building confidence for the biological mechanism of the drug on the disease. ‘A picture is worth a thousand words’ is an adage that applies heavily in the analysis of PD effects of the drug through biomarker. The rapid development of statistical methodology coupled with increasing computing power has paved the way to provide visual summaries of multiplexed data.