This article, presented by Nanopharm, an Aptar Pharma company, reviews the challenges that companies face in bringing generic respiratory and nasal therapies to market. It explores how organizations have proactively addressed these challenges and developed services to integrate the device and the formulation. The article focuses on the concept of structural Q3 equivalence for Orally Inhaled and Nasal Drug Products (OINDPs), a vital approach for the industry. It introduces SmartTrack, a process that combines the recording of inspiratory breath profiles with realistic aerodynamic particle size distribution performance testing. This approach provides the critical elements required to meet the alternative requirements and eliminate clinical endpoint bioequivalence studies, accelerating and de-risking generic product development. The article concludes by highlighting the benefits of this alternative approach, including reduced development time and cost, providing companies with a clear and compelling competitive advantage.
FDA’s Evolving Stance on In-Silico Studies in Bioequivalence Testing
The paper titled “Microstructural Characterization of Dry Powder Inhaler Formulations Using Orthogonal Analytical Techniques” explores the use of advanced analytical methods to improve our understanding of the performance of dry powder inhalers (DPIs).