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August 9, 2009

US FDA Expands GastroPlus Software Licenses

According to the company, GastroPlus simulations can provide insight into the dissolution, absorption, and pharmacokinetics of generic formulations

By CBR Staff Writer

Simulations Plus has received a purchase order from FDA to expand the number of licenses for the company’s GastroPlus simulation software.

Ron Creeley, vice president of marketing and sales at Simulations Plus, said: “This purchase order increases the number of GastroPlus software licenses at the US Food and Drug Administration by ten new licenses at the Office of Generic Drugs. GastroPlus simulations can provide agency scientists with valuable insight into the dissolution, absorption, and pharmacokinetics of generic formulations compared to innovator formulations when generic drug companies submit abbreviated new drug applications (ANDAs) to the agency.

An increasing number of generic drug companies license GastroPlus, and we expect that number to grow. If you’re in the business and you know the regulatory agency is going to analyze your data with GastroPlus, it would behoove you to find out before you submit your ANDA,” he added.

Walt Woltosz, chairman and chief executive officer of Simulations Plus, said: “We enjoy an excellent relationship with many FDA scientists in labs across the country, and we’re pleased that we can provide tools that help the agency in its daunting work of evaluating and approving new medicines. FDA scientists are among the elite in the world of pharmaceutical science, so their selection of Simulations Plus’ software products is extremely satisfying to our scientists, management, and shareholders.”

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