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FDA Signs Research Collaboration Agreement with Simulations Plus

Mon, 03/03/2014 - 8:14am

Simulations Plus, Inc., a provider of software for pharmaceutical discovery and development, announced that it has signed a five-year research collaboration agreement (RCA) with the U.S. Food and Drug Administration (FDA) to work together to determine the value of mechanistic absorption modeling (“MAM”) in developing predictive and robust in vitro-in vivo correlations (IVIVCs). The collaboration will examine how the use of MAM can provide additional insight and greater accuracy with regards to prediction of complex drug absorption characteristics. The ultimate goal is to facilitate drug and generic product development by decreasing the regulatory burden through adequate modeling approaches.

Under the agreement, Simulations Plus will provide licenses for the Company’s GastroPlus™ simulation software to model in vivo data representative of challenging absorption characteristics to the FDA's Office of Testing and Research located in the Center for Drug Evaluation and Research Office of Pharmaceutical Science. During the first year, the Company will provide training to FDA investigators regarding the underlying mathematical models. During the course of the collaboration, ideas and recommendations will be exchanged between the FDA and the Company that aim to improve MAM. The collaborators plan to make results from this research available to the public.

John DiBella, vice president of marketing and sales for Simulations Plus, said, “This is an exciting collaboration. Mechanistic IVIVC was an idea we first considered in the 1990s, yet as of today the number of users remains well below what we believe it should be. The detailed mechanistic model of drug absorption in the gastrointestinal tract in GastroPlus provides a platform for investigation that we believe will be of significance to the FDA and to companies involved in pharmaceutical and generic product research and development.”

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