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Abstract:
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Clinical trial simulation was promoted a decade ago as a tool to better understand relationships among dosing schedules, patient populations, trial design, and analysis. While much skepticism was present, many of the ideas have become ubiquitous and are clearly present in high-visibility efforts such as the FDA's Critical Path program. Questions remain about how such methods can become part of mainstream drug development, rather than a specialist activity applied to particularly difficult projects, and how new biomarker imaging techniques and genomic data can be integrated into these efforts. This talk will consider the complexities of incorporating these new sources and implications.
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