U.S. FDA Renews and Expands Gastroplustm Software License

Simulations Plus, Inc. has announced that it has received a purchase order from the U.S. Food and Drug Administration to renew one of the licenses for the Company’s GastroPlus™ simulation software and to add the newly introduced ADMET Predictor™ Module for GastroPlus.

Ron Creeley, vice president of marketing and sales for Simulations Plus, said: “This is one of several GastroPlus licenses the FDA has, and it’s the first renewal that comes up this year. With this license renewal, the scientists using GastroPlus requested and got approved an addition to their original license, our new ADMET Predictor Module.”

He continued, “This module will allow FDA scientists to load molecular structures directly into GastroPlus, which will then automatically invoke the ADMET Predictor Module to calculate the inputs needed by GastroPlus to simulate absorption for each of the molecules. The ADMET Predictor Module calculates these properties from molecular structure with the same top-rated structure-to-property prediction engine used in our full-version ADMET Predictor program, providing best-in-class estimates for physicochemical and biopharmaceutical properties for each molecule. GastroPlus takes these predictions and automatically builds a database with supporting tables to save scientists considerable time and effort.”

Walt Woltosz, chairman and chief executive officer of Simulations Plus, said: “We continue to enjoy an excellent relationship with 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.”