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Simulations Plus, FDA to Collaborate on Drug Development Study


Simulations Plus said this week that it has signed a five-year research collaboration agreement with the US Food and Drug Administration to work on determining the value of mechanistic absorption modeling (MAM) in developing predictive and robust in vitro/in vivo correlations.

Specifically, the collaborators will explore how MAM can be used to make more accurate predictions of complex drug absorption characteristics. The ultimate goal of the project, the company said in a statement, is to "facilitate drug and generic product development by decreasing the regulatory burden through adequate modeling approaches."

As part of the agreement, Simulations Plus will provide training and licenses for its GastroPlus simulation software to the FDA's Office of Testing and Research. The solution will be used to "model in vivo data [that is] representative of challenging absorption characteristics, the company said.