Medical Device Daily
A computer program designed to simulate the way drugs are absorbed in the gastrointestinal tract will be used in government-based research with the FDA’s licensing of GastroPlus software from Simulations Plus (Lancaster, California), the company said.
Walt Woltosz, chairman and CEO of Simulations Plus, told Medical Device Daily that the company has worked with the FDA for a number of years using GastroPlus for a few informal projects on the side.
“Now they’ve decided that they need it enough to purchase a license,” Woltosz told MDD.
GastroPlus is a “very sophisticated” computer program that simulates drug absorption and pharmacokinetics in the gastrointestinal tract, Woltosz said. It is typically used for oral drugs, he said, but also can be used for intravenous drugs.
“There are many complicated factors of how the drug is absorbed and where it’s absorbed in the GI tract,” Woltosz said.
The software can be used both for animals and humans, Woltosz said.
In a company statement Woltosz said the FDA’s position in advocating for better simulation and modeling tools was expressed in its white paper entitled “Innovation or Stagnation, Challenge and Opportunity on the Critical Path to New Medical Products” released in March 2004. “The medical product development process is no longer able to keep pace with basic scientific innovation. Only a concerted effort to apply the new biomedical science to medical product development will succeed in modernizing the critical path,” the FDA stated in the paper.
“We’re very pleased that the FDA has licensed GastroPlus for use in its internal research. We believe this license is an indication of the utility of GastroPlus as one of the tools the FDA and industry use in various research projects,” said Ron Creeley, VP of marketing and sales for Simulations Plus.
According to the company, some of the benefits of GastroPlus include fast analysis and understanding of the behavior of drug candidates in animals and humans; the rapid ability to test hypotheses regarding formulation, changing physicochemical parameters, fasted and fed state effects; ionization effects on solubility and absorption; and the ability to quickly estimate best dosing for toxicity studies in animals.
Financial details of the contract were not disclosed.
Simulations Plus develops drug development software used in the conduct of drug research by pharma, biotech, and drug delivery companies. It has two other businesses, Words+, and FutureLab, which are based on its software technologies.
In other grants/contracts news:
• Wyndgate Technologies (Denver), a division of Global Med Technologies, reported that Community Hospitals and Wellness Centers (Bryan, Montpelier and Archbold, Ohio) has selected SafeTrace Tx as its transfusion management system. SafeTrace Tx will be placed in all three of the organization’s hospitals. Terms were not disclosed.
Community Hospitals and Wellness Centers said it is upgrading its blood bank from paper records to an automated system to increase patient safety and replacing its entire laboratory information system. The SafeTrace Tx system will communicate with Community Hospitals and Wellness Centers’ new LIS to allow the blood bank and other departments throughout the hospital to share patient information quickly and easily, according to Wyndgate.
“We wanted a blood bank to complement our new LIS system and to help us attain our goal of increasing the level of patient safety within our organization,” said Greg Slattery, chief information officer at Community Hospitals and Wellness Centers. “[W]e believe that Wyndgate is truly a leader in its space.”
Global Med provides information management software products and services to healthcare. Its Wyndgate Technologies division supplies information management systems to U.S. and international blood centers and hospital transfusion centers.