Abstract: The invention relates to systems and methods for assessing the efficacy of an aerosol for pulmonary drug delivery as well as to an inhaler device, an orally inhaled drug product and a drug/device combination product. An aerosol can be generated by an inhaler device and comprises aerosol particles containing an orally inhaled drug product. The method comprises the steps of providing a computational lung model and a computational particle transport and deposition model, computing a spatial particle deposition distribution of discrete particles based on a determined aerosol value of an aerosol parameter, computing an efficacy value of an efficacy parameter based on the spatial particle deposition distribution and using the efficacy value for automatically assessing the efficacy for pulmonary drug delivery of the aerosol.