U.S. FDA Adds Licenses of GastroPlus™ Software

Software: GastroPlus®
Division: Simulations Plus

Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of consulting services and software for pharmaceutical discovery and development, today announced that the U.S. Food and Drug Administration has added licenses of GastroPlus™ for use in the Office of Clinical Pharmacology.

John DiBella, vice president of marketing and sales for Simulations Plus, said: “Over the years, Simulations Plus’ software has been utilized heavily by the FDA to support research by several divisions, including the Office of Generic Drugs, the Center for Food Safety and Applied Nutrition, and the Center for Veterinary Medicine. Now, several licenses of GastroPlus will be available exclusively for scientists in the Office of Clinical Pharmacology (OCP). This division is responsible for the analysis of clinical data, with emphasis on the study of population variability (in both healthy and patient subject groups) and drug-drug interactions. The use of physiologically based pharmacokinetic (PBPK) modeling to assist with various facets of clinical research is becoming more widespread, and we are excited that GastroPlus, with its industry-leading capabilities, will be applied by the division in these areas.”

Dr. Viera Lukacova, team leader for simulation technologies at Simulations Plus, added: “Our group will be hosting a GastroPlus workshop for OCP scientists in the coming months, with over 35 already confirming their attendance. We look forward to training them on the use of the software and helping them to learn how it can be improved to help the agency in their recent initiative to incorporate modeling & simulation in the evaluation and approval of new medicines.”