ABSTRACT

The development of inhaled drug products is an expensive and lengthy process, and the risk of failure at different stages of the development life cycle is high. Improved preclinical tools that can accurately predict the in vivo response are urgently required to help address these issues. In Chapter 6, we briefly review the current preclinical models used in inhaled drug development and their limitations, and outline the unmet needs for better tools for translation. Three-dimensional platforms offer a number of potential advantages as tools for translation, and these are outlined in the chapter. A range of respiratory models with a 3D architecture, including scaffolds, multicellular spheroids, and microfluidic biochips, as well as those that aim to recapitulate respiratory diseases, are also described. How these systems could practically be introduced as part of inhaled drug product development is reviewed.