Model-informed drug development approach that supports GDUFA top research priorities from 2019 to present.

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The high failure rate in drug development is a major problem. The need for more cost-effective and -efficient drug development is widely recognized but largely unmet. A proposed solution is the development of research and teaching programs in quantitative systems pharmacology (QSP), as recommended by the 2011 U.S. National Institutes of Health [...]

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