DIA / FDA / PhRMA Course

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Ted Grasela led a breakout session called Model Development Using Accumulating Data, What About Model Validation? with Lei-Nie and Sue-Jane Wang of the FDA during the course Modeling and Simulation in Drug Development: Quantitative Approaches for Decision Making, which was jointly sponsored by the Drug Information Association, the Food and Drug Administration, and the Pharmaceutical Research and Manufacturers of America. The course was held October 28 to 29, 2009, in Bethesda, Maryland.

From the course description:
“The FDA Critical Path Initiative has stimulated interest in new tools and ways to improve the efficiency and success rates of drug development programs, including their planning and analysis. . . . Among the opportunities being explored is the increased use of quantitative modeling and computer simulation (M&S) tools and approaches. There is broad consensus that modeling and simulation has an enormous potential, in many cases already realized, to greatly improve drug development through better clinical study and program design, more effective approaches to dose selection and regimen optimization, as well as better assessment of the risk/benefit of new and existing treatments.”