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March 3, 2014
08:02 EDTSLPSimulations Plus signs five-year reseaerch collaboration agreement with FDA
Simulations Plus has signed a five-year research collaboration agreement with the U.S. Food and Drug Administration to work together to determine the value of mechanistic absorption modeling in developing predictive and robust in vitro-in vivo correlations. 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.
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