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.
Simulation in In Vitro Bioequivalence for Particle Sizes
Explore Simulation-informed design in in-vitro bioequivalence trials for particle size distributions’ performance.
Challenges in OINDPs Achieving Q3 Equivalence
Nanopharm review the bioequivalence challenges for OINDPs by achieving Q3 structural equivalence.
