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27 Sep 2023

SmartTrack™ Brochure


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.

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Nanopharm Announces Exclusive Collaboration With Fluidda To Accelerate Regulatory Pathway For OINDP Using SmartTrack

Crystal Lake, Illinois, September 22, 2022 – Nanopharm, an Aptar Pharma company and leader in contract research and development services for orally inhaled and nasal drug products (OINDPs), today announced an exclusive collaboration with Fluidda, a leader in the field of Functional Respiratory Imaging. The companies will leverage their respective proprietary technology platforms to help accelerate U.S. Food & Drug Administration (FDA) approvals for orally inhaled generic products (OIDPs) via the alternative bioequivalence pathway. Nanopharm was acquired by Aptar (NYSE: ATR) in 2019, as part of the company’s strategy to expand its services offerings and partner with pharmaceutical companies earlier in the drug development process.

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