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Beskrivning
| Land | Sverige |
|---|---|
| Lista | Spotlight |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
(Stockholm, 05 May 2023) Following its communication on April 18, 2023, regarding completion of the required administrative routines necessary to proceed with its FDA BAA (Broad Agency Announcement) contract research project, ISAB today announces that it has now received the formal clearance to begin the experimental phase of the study. The study is now commencing at the company's facilities in Sweden.
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.
Manoush Masarrat, CEO
E-mail: Manoush.masarrat@inhalation.se
Mobile: +46 (0)73 628 9153