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.

Articles
Balancing Creativity with Compliance: Meet Kirsten Searle, Manager of Pharma Development
Discover how Kirsten Searle is enhancing project management excellence at Nanopharm. Hear about her philosophy on balancing pragmatic process with scientific innovation in a fast-paced CRO environment.

