Biomarkers and biomeasures: key enablers for pharmacokinetic–pharmacodynamic modeling in drug discovery and development

"While biomarkers quantitatively measure perturbations to the system anywhere in the causal path between drug administration and clinical effect … biomeasures are quantitative information about drug-independent system properties … required to predict drug action." For more than a decade, pharmacokinetic-pharmacodynamic (PK/PD) modeling and simulation (M&S) has been routinely applied during medicine research and development (R&D) to help in the design, analysis and interpretation of clinical trial data. It is now being recognized that successful implementation of PK/PD reasoning in early drug discovery could also have a substantial impact on the overall efficiency and success of pharmaceutical research by identifying compounds...