Otimização de processos no desenvolvimento de produtos inalatórios orais e nasais.

For those working in drug delivery, time to market is critical. This webinar (which is in Portuguese) discusses some of the challenges associated with the development of Orally Inhaled and Nasal Drug Products (OINDPs) and introduces SmartTrack™, a solution that can optimize and accelerate the pathway to success, by bridging relevant in vitro measurements to in vivo performances. SmartTrack™ is delivered by Nanopharm, an Aptar Pharma company and world leader in OINDP drug development seervices. It incorporates the use of clinically relevant mouth-throat models, dissolution testing, advanced in silico modelling and simulation tools to guide and derisk the development journey. The regulatory framework for OINDPs is also discussed and a possible alternative bioequivalence pathway to the current US FDA ‘weight of evidence’ approach is explored.