Advancing Alternative Bioequivalence for OINDPs
Nanopharm & Fluidda explore FDA’s progress in alternative bioequivalence for OINDPs, Model Master Files (MMF), and future regulatory pathways.
In Silico Bioequivalence Beyond Generic Drug Development
Nanopharm & Fluidda discuss FDA’s in silico bioequivalence methods for alternative pathways beyond generics in inhalation drug development.
FDA’s Evolving Stance on In-Silico Studies in Bioequivalence Testing
Discover how the FDA’s evolving view on in-silico methods, with insights from Nanopharm and FLUIDDA, impacts bioequivalence and generic drugs.
FDA New Inhaled Product Guidelines: Bioequivalence & PSGs
Explore Nanopharm & Fluidda discuss FDA’s revised inhaled product guidelines (PSGs) and alternative bioequivalence pathways for generics.
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.
