Model Firsts: How QSP can Pick the Right Dose for First-in-Human Trials

Abstract

By combining disparate data into coherent mechanistic models, quantitative systems pharmacology is becoming a key tool for picking the right dose for first-in-human trials and other early make-or-break decisions. Advocates see it as part of an expanding toolbox of models that can yield better safety and efficacy predictions from preclinical data, and want regulators to include it in their guidances.

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