Inhalation Sciences receives green light from the US FDA to start the experimental phase of FDA BAA dissolution research project

REG

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) efforts. The proposed work was approved by the FDA Center for Drug Evaluation and Research (CDER).

ISAB’s CEO Manoush Masarrat: “We are delighted to begin this important work. The cooperation and collaboration between ourselves and our esteemed colleagues at the US FDA has been excellent. We look forward to moving ahead and delivering the outcomes of this important project and are thrilled that we can follow the time plan initially outlined”.

This research project is planned to be finalized by September 2024.

Datum 2023-05-05, kl 08:30
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