Inhalation Sciences: clarification to previous press releases (published Jan 18, May 5, Aug 4, 2022) regarding the planned FDA study
(Stockholm, 15 September 2022) Inhalation Sciences Sweden AB has been granted a BAA contract for dissolution research purposes. The project objective is to evaluate the discriminative power of the ISAB equipment DissolvIt® 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), not the NCTR, as previously stated.
ISAB’s CEO Manoush Masarrat: “This is a great opportunity for ISAB, and we are very happy to have this approval and thereby be further able to evaluate the full potential of the method. ISAB strives for its DissolvIt® technology to be the new method recommended for use to evaluate the dissolution of inhalable substances in the lung.”
Please note that the contract with CDER is for research only, no endorsement or recommendation of the method has been made by the FDA.
