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This case study focuses on the optimization of batch selection to increase the success of Pharmacokinetic (PK) studies for bioequivalence (BE). PK studies are a critical part of the regulatory pathway for new generic inhaled products, providing evidence of required bioequivalence with the reference listed product.
Nanopharm’s SmartTrack™ approach employs a combination of clinically relevant in vitro analytical tests and PBPK (Physiologically based pharmacokinetic) modeling to predict pharmacokinetic behavior among candidate batches with inherently variable properties. These services provide the means to optimize formulation development and pre-screen both test and reference batches prior to initiating the clinical study, while also training patients in consistent use of the device.
The goal is to remove unwanted variability from these aspects of the process, making pharmacokinetic studies more predictable and less risky, instilling confidence that your test product will deliver results in line with expectation, providing the necessary evidence of BE to support regulatory submissions with reduced risk, time and cost.
The case study also highlights the challenges faced in the process. Variability between batches of test or reference products can be tested in vitro, but translating the in vitro data into in vivo predictions is challenging. Furthermore, accounting for innate variability between patients is even harder, such is human physiology and behavior.
To overcome these challenges, Nanopharm employed realistic APSD data (rAPSD, aerodynamic particle size distribution ), collected breathing profiles from untrained patients using the Nanopharm Inhalation Profiler (NIP™), and developed a PBPK model to predict PK. The resulting modeling data showed greater correlation with the actual clinical data returned from the Pilot PK study.
