{"entity":{"id":"quantitative-systems-pharmacology","kind":"technology","name":"Quantitative systems pharmacology (QSP)","aka":[],"tldr":"Mechanistic computer models that join a drug's pharmacology to the biology of the tumour and the body, used by developers and regulators to pick doses, predict combinations and explain why a trial failed.","summary":"Quantitative systems pharmacology couples pharmacokinetics with mechanistic models of signalling pathways, cell populations and organ systems. In oncology it has been used to predict the exposure-response of checkpoint inhibitors, to design bispecific and CAR-T dosing that limits cytokine release, to simulate resistance to targeted drugs and to support regulatory submissions under the FDA's model-informed drug development programme. Project Optimus, the FDA's 2021 initiative to end maximum-tolerated-dose defaults for targeted drugs, leans on these models to justify lower doses.","status":"established","asOf":"2026-09-17","links":[{"label":"FDA Project Optimus","url":"https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus"}],"tags":["mathematical-model"],"related":[],"cancers":[],"sections":["ai-computation","drug-discovery"],"technologies":["pkpd-modelling","oncology-pharmacogenomics","digital-twins-trials"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"principle":"Systems of differential equations link drug concentration to receptor occupancy, pathway activity, cell kill and clinical markers, calibrated to preclinical and clinical data and used to simulate untested regimens.","strengths":["Accepted by regulators for dose justification","Predicts combinations before trials","Integrates disparate data"],"limitations":["Large models are hard to validate","Parameter uncertainty is often understated","Expertise concentrated in industry"],"since":2011},"route":"/technologies/quantitative-systems-pharmacology/","neighbours":{"section":[{"id":"ai-computation","kind":"section","name":"AI & Computation","route":"/fronts/ai-computation/"},{"id":"drug-discovery","kind":"section","name":"Drug Discovery Platforms","route":"/fronts/drug-discovery/"}],"technology":[{"id":"digital-twins-trials","kind":"technology","name":"Digital twins and virtual control arms","route":"/technologies/digital-twins-trials/"},{"id":"digital-twin-patient-models","kind":"technology","name":"Patient digital twins","route":"/technologies/digital-twin-patient-models/"},{"id":"oncology-pharmacogenomics","kind":"technology","name":"Pharmacogenomic testing before chemotherapy","route":"/technologies/oncology-pharmacogenomics/"},{"id":"pkpd-modelling","kind":"technology","name":"Pharmacokinetic and pharmacodynamic modelling","route":"/technologies/pkpd-modelling/"},{"id":"immune-tumour-dynamics-models","kind":"technology","name":"Tumour-immune dynamics models","route":"/technologies/immune-tumour-dynamics-models/"}]}}