This document provides guidance on how to present the results of a population pharmacokinetic analysis, in order to provide a level of details that will enable a secondary evaluation (i.e. assessment by regulatory authorities of the conducted analysis and conclusions drawn).
Keywords: Nonlinear mixed effects modelling, population modelling, pharmacokinetics, pharmacodynamics, PKPD, analysis plan, data description, model selection, model evaluation, reporting, population pharmacokinetics