➡ Presentation of SmartTrack approach to derisk and accelerate generic product development as a biowaiver for clinical end point studies. Introduction of the in vitro and in silico tools comprising SmartTrack platform under the umbrella of bioequivalence studies for generic orally inhaled products.
➡ Presentation of SmartTrack in silico tools by Fluidda: Functional Respiratory Imagining and Rapid Deposition Analysis. Opportunities versus limitations and how, if combined together into the SmartTrack platform, they can make clinical trials shorter, faster and thus, more cost effective.
➡ Presentation of SmartTrack realistic in vitro tools by Nanopharm and their application in a regulatory submission of a dry powder inhaler bioequivalent product.