GDUFA: FDA adds further weight to modelling and simulation’s role in bioequivalence
GDUFA 2026: FDA strengthens role of modeling & simulation for inhaled generic drug bioequivalence. Learn how this shift enhances efficiency for OINDP development.
Optimizing OINDP Regulatory Paths With Model Master Files (MMF)
Streamline OINDP regulatory submissions with Model Master Files—confidential, reusable models that accelerate drug development and U.S. FDA review.
Accelerating OINDP Development with Nanopharm
Discover how Nanopharm, supports OINDP development from preclinical to CGMP with SmartTrack™, in silico modeling, and regulatory expertise.
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.
Novel Aerosol Apparatus for Inhaler Testing in OINDPs
Explore a case study for UniDose in the development of a novel aerosol collection apparatus for dissolution testing of orally inhaled drugs.
Nanopharm Case Study on Computational Modelling
Accelerate injectable drug reformulation for nasal delivery using modelling. Uncover clinical benefits and innovation in nasal pharmaceuticals.
Nanopharm’s SmartTrack: Accelerating OINDP Respiratory Drug Delivery
Revolutionize your OINDP respiratory drug delivery with Nanopharm’s SmartTrack. Accelerate development and mitigate risks through expert formulation and integrated solutions. Your pathway to success starts here.
