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Beskrivning
Land | Sverige |
---|---|
Lista | Spotlight |
Sektor | Hälsovård |
Industri | Medicinteknik |
(Stockholm, 18 March 2022) Inhalation Research Services (IRS) has signed a contract worth 74 000 Euros for a research project with a leading developer of inhaled generics. The project will compare in vitro data from ISAB's dissolution module DissolvIt® with in vivo data from healthy volunteers, producing more milestone evidence of DissolvIt's ability to produce predictive IVIVC (In Vitro-In Vivo Correlated) data. In January 2022 ISAB submitted a White Paper to the FDA aiming to validate DissolvIt® to become a recommended dissolution method for inhaled drug tests.
IRS, the Contract Research Organization of Inhalation Sciences AB (ISAB), has signed a new order worth 74 000 Euros for a research project with a leading developer of inhaled generics headquartered in Switzerland. The new project will use ISAB's leading in vitro dissolution module DissolvIt® to gather `IVIVC' data - data that compare and correlate in vitro data with pharmacokinetic in vivo data the company has previously gathered form healthy volunteers.
IVIVC data are highly sought after, enabling drug developers to predict in the preclinical in vitro research stage how a compound will eventually behave in the clinical stage when tested on humans. DissolvIt® has been increasingly recognized as a leading solution for dissolution data with strong In Vitro In Vivo Correlation. In 2021 for example the paper "In Vitro to ex Vivo/In Vivo Correlation (IVIVC) of dissolution kinetics from inhaled particulate solutes using air/blood barrier models" was published in the Journal of Aerosol Science. In January 2022 ISAB submitted a study protocol to the US FDA aiming to validate DissolvIt® as an FDA-recommended technology and, ultimately, a new standard research method for inhaled drug research.
ISAB CEO Manoush Masarrat: "This is a prestigious, leading company within the inhaled generics space, and we welcome their appreciation of our unique capabilities - and the value it will provide. The data generated here can add to our already robust evidence on DissolvIt's IVIVC capabilities and serve as a strong basis for future collaboration."
Manoush Masarrat, CEO
E-mail: Manoush.masarrat@inhalation.se
Mobile: +46 (0)73 628 9153