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FDA Adopts Pharsight Simulation Program for HIV Drug Development

NEW YORK, Feb. 25 (GenomeWeb News) - The US Food and Drug Administration has used a quantitative-based modeling and simulation program designed by Pharsight to help it design an end-of-Phase IIa trial for an anti-HIV drug, Pharsight said today.


The relationship between Pharsight and the FDA is partly the result of the agency's EOPIIa program, which is part of the Critical Path Initiative. The program enables the FDA to provide sponsors of clinical trials with input earlier in the drug-development cycle.


Pharsight said it believes that quantitative-based modeling and simulation during drug development can increase the productivity and efficiency of the process.

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