Beyond Population-Level Targets for Drug Concentrations: Precision Dosing Needs Individual-Level Targets that Include Superior Biomarkers of Drug Responses.

Abstract

The purpose of precision dosing is to increase the chances of therapeutic success in individual patients. This is achieved in practice by adjusting doses to reach precision dosing targets determined previously in relevant populations, ideally with robust supportive evidence showing improved clinical outcomes compared with standard dosing. But is this implicit assumption of translatable population-level precision dosing targets correct and the best for all patients? In this review, the types of precision dosing targets and how they are determined are outlined, problems with the translatability of these targets to individual patients are identified, and ways forward to address these challengers are proposed. Achieving improved clinical outcomes to support precision dosing over standard dosing is currently hampered by applying population-level targets to all patients. Just as "one-dose-fits-all" may be an inappropriate philosophy for drug treatment overall, a "one-target-fits-all" philosophy may limit the broad clinical benefits of precision dosing. Defining individual-level precision dosing targets may be needed for greatest therapeutic success. Superior future precision dosing targets will integrate several biomarkers that together account for the multiple sources of drug response variability.