In recent weeks, ISAB has received several requests and these two formal orders reinforce the picture of a growing need for accurate and regulatory relevant data in inhalation research.

A key driver behind this development is the recent announcement by the U.S. Food and Drug Administration (FDA) of new guidelines and initiatives to reduce and eventually replace animal studies in drug development[1]. In this change, reliable in vitro methods play a central role.

ISAB's platforms are specifically designed to meet these new regulatory needs, including enabling controlled particle exposure, realistic lung imaging and simulations of lung dissolution dynamics. This provides customers with robust data that both supports internal development and facilitates regulatory communication.

“We see a clear trend: regulatory authorities are increasingly demanding alternative test methods with high physiological relevance,” says Manoush Masarrat, CEO of Inhalation Sciences. “The fact that returning customers are choosing PreciseInhale® and DissolvIt® in new projects shows that our technology is well positioned for a new era in drug development - where animal-free, predictive models are a crucial part of regulatory approval.”

For more information about Inhalation Sciences, please contact:

Manoush Masarrat, CEO>
Mobile: +46 (0) 73 628 9153
E-mail: manoush.masarrat@inhalation.se

About Inhalation Sciences Sweden AB (publ)

Inhalation Sciences Sweden AB (publ) develops and commercializes world-leading instruments and services for research into inhalation. The company’s patented lab instruments PreciseInhale® and DissolvIt® enable researchers in the pharma industry to make drug pipeline decisions at an early stage, saving time and resources for R&D departments, and enables researchers in academic institutions to define how aerosols and small particles impact our lungs, and so our health, when being inhaled.