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SmartTrack™

SmartTrack™ is an alternative digital platform using that uses real patient data with with in vitro testing and in silico models to support bioequivalence for inhaled drugs

Explore the Platform Why SmartTrack?

SmartTrack™ is an advanced alternative bioequivalence platform that accelerates and derisks inhaled drug product development through an integrated digital platform that utilizes real world patient data combined with advanced in vitro tests and in silico simulations to support claims of bioequivalence for generic orally inhaled and nasal drug products (OINDPs). The SmartTrack™ platform has been developed over the last decade to support the justification of biowaivers for comparative clinical endpoint (CCEP) studies with ongoing interaction with the U.S. FDA.

SmartTrack™ can provide sponsors with shorter inhaled drug development times along with data driven support for regulatory filings.

SmartTrack was developed in a collaboration between:

Nanopharm – A specialist CRO for nasal and inhaled drug products

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FLUIDDA – A global leader in Functional Respiratory Imaging (FRI)

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Digital Bioequivalence

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Real-world patient breathing profiles

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Method development using CFD

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PK simulation via PBPK

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Realistic in vitro aerosol testing and lung deposition modelling using CFD and RDA

Digital_Bioequivalence_icon Building weight of evidence
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The SmartTrack™ alternative bioequivalence platform uniquely:

  • Uses real patient data to account for individual and population variability
  • Incorporates real-world disease specific physiologies
  • Helps us understand variances in in vitro data and account for patient variability
  • Avoids idealized scenarios in such a complex dynamic such as the lung
  • Participates in direct sponsored research and workshops with the U.S. FDA
  • Delivers a credible and validated* option as supportive evidence to updated product Product-Sspecific Guidances (PSGs)

*Validation study ongoing – expected completion end 2026.

Digital Evidence for Bioequivalence

SmartTrack™ is a faster and more data-driven alternative pathway to build a solid base of evidence and understand the root cause of the observed differences between clinical and in vitro datasets.

SmartTrack™ can help to reduce the ambiguity and number of follow-on questions from regulators by providing a comprehensive weight of evidence analysis of the bioequivalence data.

SmartTrack™ Details

The SmartTrack™ platform answers many of the common questions sponsors/drug developers have about how they derisk and accelerate the development of their inhaled drug products

What are the challenges of developing inhaled generic drug products?

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What is SmartTrack?

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How does SmartTrack Work?

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What does Functional Respiratory Imaging (FDI) add?

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How do regulators view SmartTrack™?

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Making the Case for SmartTrack™

Not only is SmartTrack™ an ideal digital bioequivalence platform for generic orally inhaled drug products, but it also offers significant benefits to many other OINDP applications.

The Case for SmartTrack™
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SmartTrack™ Advancing Inhaled Drug Development

Nanopharm and FLUIDDA's SmartTrack™ is an integrated digital evidence platform that can demonstrate bioequivalence faster and reduce reliance on comparative clinical endpoint (CCEP) studies. It does so in a single integrated simulation framework that reliably predicts the real-world performance of inhaled drug products in humans.

It can help scientists and regulators to better understand the variances evident in in vitro data and accounts for patient variability that may not be apparent in traditional systemic PK driven studies performed under a weight of evidence approach.

Contact Nanopharm today and accelerate
your inhaled product development program with SmartTrack™

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