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.
Nanopharm Newsletter November 2024
Nanopharm is leading innovation in OINDP, inhalation, and nasal drug delivery with FDA collaboration and advanced spray-drying technology.
FDA New Inhaled Product Guidelines: Bioequivalence & PSGs
Explore Nanopharm & Fluidda discuss FDA’s revised inhaled product guidelines (PSGs) and alternative bioequivalence pathways for generics.
Interview with Jane Provis Evans, Head cGMP services at Nanopharm
In the ever-evolving world of pharmaceuticals, the importance of stringent quality control cannot be overstated. This interview with Jane Provis-Evans, Head of cGMP Analysis at Nanopharm, sheds light on the critical role of cGMP testing in the development and optimization of drug-device combinations, particularly for orally inhaled and nasal drug products (OINDPs). With the launch of Nanopharm’s new GMP services, the company is well-positioned to help clients bring innovative treatments to patients.
Dry Powder Inhaler Formulations: Microstructural Analysis Techniques
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).
