Inhalation Sciences begins planned FDA BAA dissolution research project
(Stockholm, 14 November 2022) In September 2022 Inhalation Sciences Sweden AB (ISAB) was awarded an FDA BAA (Broad Agency Announcement) contract for a research project evaluating the discriminative power of its DissolvIt® in vitro dissolution technology. The project has now had its Kick-off meeting and is underway. ISAB has communicated previously on this project, most recently on 15 September 2022.
The objective of contract 75F40122C00197 is to evaluate the discriminative power of ISAB’s DissolvIt® technology by comparing drug formulations, aimed for administration via inhalation, with small differences. The project scope also includes in vitro in vivo correlation (IVIVC). The proposed work was approved by the FDA Center for Drug Evaluation and Research (CDER).
ISAB’s CEO Manoush Masarrat: “We are pleased to have begun work on this project. It is a valuable opportunity for us to further explore the potential of the DissolvIt® method in evaluating the dissolution of inhalable substances in the lung.”
