The opportunity to apply our exclusive SmartTrack™ platform goes beyond just the demonstration of bioequivalence of orally inhaled drug products. SmartTrack™ can accelerate the development process by integrating real patient data, in vitro testing and in silico computational modeling to reliably predict lung deposition and bioavailability, while conducting fewer clinical studies.
SmartTrack™ can provide data to support early development decision making, a more accurate mechanistic understanding of the drug delivery process and support provide a stronger regulatory justification for regulatory product approval. There are numerous a number of advantageous applications that can benefit from for the SmartTrack™ platform.
SmartTrack™ can be used to help demonstrate the bioequivalence of a new generic inhaler drug product to a reference listed drug (RLD), supporting justifications around potentially overdiscriminating in vitro data, without having to default to costly, time consuming comparative clinical endpoint studies (CCEPs) that lack sensitivity.
SmartTrack™ can be used to benchmark regional deposition and bioavailability of a reformulated orally inhaled drug product against the currently approved product in a different dosage form or device, helping with dose selection, product optimization and minimizing clinical development cycles. SmartTrack™ can contribute to an accelerated reformulation process and a derisked regulatory review process.
When replacing a current hydrofluoroalkane (HFA) propellant with a Next Generation Propellant (NGP) in an existing pressurized meter dose inhaler (pMDI), substantial product redevelopment is required from valve selection, formulation modifications and comparison of aerosol performance to match the dose. SmartTrack™ can be used to optimize the development process and understand if and how non-Q2 products are still equivalent, while generating data ready for regulatory submission. Our research contract with the U.S. FDA puts us in a strong position to share gained insight with the industry.
SmartTrack™ can also be applied to nasal spray products, where for certain indications the its regional deposition is key to its performance for certain indications. Whether targeting the olfactory region for nose-to-brain delivery, or screening permeation enhancers to achieve rapid systemic absorption, SmartTrack™ can give you rapid insight into how your drug is behaving following delivery.
Please review the following case studies to learn more about how SmartTrack™ has been successfully applied to inhaled drug development and bioequivalence studies.
Choice of anatomical throat model, breathing profile and actuation point all impact mass balance and impactor sized mass (ISM) parameters. They also show different variations batch to batch and therefore affect the resulting T/R ratios. Using one team with modeling and test method expertise can expedite method development by exploring the sensitivity of different critical variables on the outcomes based on product and batch specific data.
Clinical studies do not discriminate between patients with different lung anatomies. This means , meaning the new rAPSD methods could be overdiscriminating once patient-to-patient variability is accounted for. RDA takes pooled rAPSD data that is processed to better represent the patient population and uses it in models of regional lung deposition in patient models simulations to evaluate whether patient variability brings the pivotal dataset into acceptable clinical limits of bioequivalence. This can help to , and thus justify accepting the acceptance of PBE results that are marginally outside of the standard acceptance criteria.
