Rethinking bioequivalence for nasal suspensions: Adopting an in-vitropathway with confidence
Discover how MDRS provides a regulatory-accepted alternative to clinical endpoint studies for nasal suspension bioequivalence. Learn to de-risk your ANDA pathway today.
Automating pMDI Actuation for Consistent In Vitro Bioequivalence Testing
Discover how automated pMDI actuation improves consistency and reduces analyst variability in in vitro bioequivalence testing, supporting realistic APSD analysis and FDA expectations.
Targeting accelerated progress at the IPAC-RS Nasal Innovation Forum 2025
Explore how Nanopharm presented strategies for accelerating patient-centric nasal product development at the IPAC-RS Nasal Innovation Forum 2025. Dive into key insights on regulatory science, advanced bioequivalence methods, and targeted drug delivery.
Aligning Alternative Bioequivilence with U.S. FDA: Advancing aerosol dose collection to enhance in vitro dissolution studies
Discover how Nanopharm’s DissoHale system advances aerosol dose collection and dissolution testing to support FDA-aligned alternative bioequivalence for OIDPs.
Microstructural Characterization of Dry Powder Inhaler Formulations Using Orthogonal Analytical Techniques
Microstructural Characterization of Dry Powder Inhaler Formulations Using Orthogonal Analytical Techniques
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.
