➡ The potential of PBBM modelling to understand and predict the pharmacokinetics of inhaled medicines will be discussed. This will include predictions of PK parameters such as AUC and Cmax based on critical product attributes such as dissolution, dose deposition and delivered dose in support of pivotal bioequvalence studies.
➡ From a biopharmaceutical standpoint, critical product and drug attributes describe the extent to which the dose reaches the lung, dose penetration into the distal parts of the lung, dissolution rate in situ, permeation through lung epithelium and diffusion through lung tissue into the systemic circulation
➡ PBBM models mechanistically describe the processes involved and allow for the prediction of systemic and local exposure following administration of an inhaled medicine. This provide opportunities to predict bioequivalence between products, define clinically relevant product design specifications, as well as the potential of novel and repurposed drugs for inhalation.