Pharmacological, mathematical, and statistical methodologies to characterise exposure-response relationships as a basis for determining the best dosing regimen.

The pharmacokinetic and pharmacodynamic (PK/PD) index, magnitude of the PK/PD index, population PK models and probability of target attainment (PTA) are used to predict the best dose for late-stage clinical trials. Robust clinical PK/PD analyses also require an accompanying robust non-clinical PK/PD package.

See also dosing and dose fractionation study.