How quantitative systems pharmacology can pick the right dose for first-in-human trials
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.
Moreover, they argue the disastrous outcome of the 2016 Phase I BIA 10-2474 trial could have been avoided if published QSP studies on parallel compounds had been taken into account. ...
BCIQ Company Profiles
European Medicines Agency (EMA)
BCIQ Target Profiles