The latest newsletter from Nanopharm, a leader in the development of orally inhaled and nasal drug products (OINDPs), provides an insightful overview of the company’s innovative SmartTrack™ process. This process, which combines in vitro and in silico models, is revolutionizing the field of OINDP development by offering an alternative pathway to traditional clinical end-point studies. 

The newsletter highlights the potential of alternative bioequivalence, a concept that is reshaping the FDA approval process for generic OINDPs. This shift could lead to significant cost savings, with the potential to save over $5 billion by eliminating the need for clinical endpoint BE studies for nasal and inhaled products.

The newsletter also reviews the role of Physiologically-based Pharmacokinetic (PBPK) models in the development of OINDPs. These models, which provide mathematical descriptions of drug transportation from the point of entry into the body to excretion, are instrumental in predicting clinical outcomes and validating the model itself.

Furthermore, the newsletter discusses the strategic collaboration between Nanopharm and Fluidda, a leader in the field of Functional Respiratory Imaging (FRI). This partnership enhances the SmartTrack™ offering and underscores Nanopharm’s commitment to advancing the field of drug delivery. The newsletter is a testament to the expertise and innovative services that Nanopharm brings to the exciting field of OINDP development.