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.

QSP Model of a Masked, Tumor-Activated Antibody

Collaboration with CytomX Therapeutics - Published in CPT: Pharmacometrics & Systems Pharmacology

13
Sep
Exploring ADC Pharmacokinetics Using QSP Modeling Strategies
Sep 13, 2017

Early Feasibility Assessment

In this case study, our partner was at the target selection stage for a bispecific agent that would hopefully work across four potential indications. They had confirmed one target, the anchor epitope (Target A), but were undecided as to the second target (Target B); based on the biology of their indications, they had 90 potential targets from which to choose, all with equally compelling biology as the project was very early.   

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