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Nanopharm & Fluidda interviews on SmartTrack: in vitro-in silico approaches for demonstrating bioequivalence for OINDP
To support generic drug companies in obtaining a market license for their orally inhaled drug products (OIDPs), Nanopharm and FLUIDDA entered into an exclusive collaboration to combine Nanopharm’s SmartTrack™ with FLUIDDA’s Functional Respiratory Imaging technology to create a unique in-vitro in-silico platform. This allows pharma companies to shorten their clinical pathways – and potentially avoid comparative clinical endpoint studies by demonstrating a holistic understanding of both the product and patient-specific variables associated with the performance of their drug product, without having to go into the clinic.
In this interview at the ERS convention in Barcelona, Gemma Budd, Director Business Development of Nanopharm, an Aptar Company, and Dr Jan De Backer, CEO of Fluidda, explains the context behind the industry and regulatory need and what the technologies offer in response.
Click here to see the short video on LinkedIn