In the realm of generic respiratory products, the FDA approval process has been a significant hurdle. However, Nanopharm’s SmartTrack™ offers an alternative solution that is reshaping the landscape. This article delves into the intricacies of SmartTrack™, a process that combines breath profiles recording with realistic aerodynamic particle size distribution performance testing, in-vitro dissolution, and morphology directed particle sizing and chemical imaging of a representative lung dose and regional deposition modelling.
The SmartTrack™ process is designed to meet the alternative bioequivalence (BE) requirements to clinical endpoint BE studies, addressing the high costs associated with clinical trials. The article highlights the potential savings of over $5 billion that could be achieved by removing clinical endpoint BE studies for both nasal and inhaled products.
The article also discusses the new FDA BE guidance for Qvar Redihaler, which provides an alternative pathway to the currently recommended comparative clinical endpoint BE study. This alternative approach is supported by the SmartTrack™ process, which has been specifically developed by Nanopharm to expedite the requirements of an alternative BE approach for orally inhaled and nasal drug products.
