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).
Nanopharm & Fluidda Discuss FDA’s New Inhaled Product Guidelines

Explore how alternative bioequivalence methods, including computational fluid dynamics and in silico modeling, are shaping the future of generic drug approval.