Creating a Roadmap to Quantitative Systems Pharmacology–Informed Rare Disease Drug Development: A Workshop Report

One of the goals of the Accelerating Rare Disease Cures (ARC) program in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA) is the development and use of regulatory and scientific tools, including drug/disease modeling, dose selection, and translational m...

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Veröffentlicht in:Clinical pharmacology and therapeutics 2024-02, Vol.115 (2), p.201-205
Hauptverfasser: Bai, Jane P.F., Stinchcomb, Audra L., Wang, Jie, Earp, Justin, Stern, Sydney, Schuck, Robert N.
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Sprache:eng
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