DELFT, Netherlands, March 11, 2024 /PRNewswire/ — InnoGI Technologies, formerly The TIM Company, announced today that The U.S. Food and Drug Administration (FDA) acquired a tiny-TIMsg System. This system is part of InnoGI Technology’s SurroGUT™ platform, which provides invitro gastrointestinal research solutions. The funding for this acquisition was enabled through FDA contract #75F40123P00476.
In the acquisition document, it was stated that the FDA’s Office of Pharmaceutical Quality Research (OPQR) is currently investigating the efficacy, quality, and safety of oral drug products, crucial for assessing marketed drugs. OPQR has requested a system capable of faithfully replicating the complex gastrointestinal conditions in both adults and children to enhance their comprehension of oral drug absorption in the gastrointestinal tract. Traditional dissolution research equipment needs to account for important physiological processes of the gastrointestinal tract, potentially limiting the quality and applicability of the results when compared to real-life situations. After a thorough evaluation of OPQR, the tiny-TIMsg emerged as the only available solution in the market that could perfectly align with the FDA’s research requirements. The system’s purchase is aimed at supporting OPQR’s crucial work in evaluating the quality and safety of oral drug products.
InnoGI Technologies provides innovative CRO services to the Pharmaceutical and Food Industries related to Gastrointestinal (GI) research and Oral Drug Delivery. It utilizes the most advanced and accurate gastrointestinal technology, mimicking the dynamics of a real human gut (SurroGUT™). It has shown a correlation range of 76% to 99.9% with human formulation rankings, outperforming dogs’ 37% correlation rate.
OPQR obtaining the tiny-TIMsg represents a substantial …
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