SOLUTIONS
For a better prediction of clinical efficacy and safety profiles
Quantitative Systems Pharmacology (QSP) modeling is a mechanistic approach to predict the pharmacodynamics, target engagement, and disease modulation of drugs.
Pathophysiology
and biology of the disease state
Mechanism of Action (MoA)
of the drug candidate and its functioning
Biological network data
on signaling pathways and cascades
Target binding
and downstream cellular regulation
Connecting all this information in one model is possible with QSP analysis to help you better understand the biological impact of your compound and its translation from preclinical models to clinical efficacy.
Mechanism of Action and Disease Progression in Drug Development
Understanding the interaction between a drug and the biological system is crucial in drug development. These dynamics determine how a drug engages its target, modulates biological networks, and ultimately alters the course of a disease.
Modeling and simulation, especially through QSP approaches, enable the prediction of these complex interactions by considering target binding kinetics, feedback loops, and homeostasis, as well as the variability in patient pathophysiology.
These tools facilitate target validation and biomarker selection while reducing the risk of efficacy failure in late-stage trials, thereby accelerating drug development and enhancing the understanding of therapeutic outcomes.
The QSP study approach enables you to test in silico different therapeutic scenarios and hypotheses that will be evaluated in Proof-of-Concept (PoC) studies.
In addition, by avoiding ineffective trials on non-responsive patient groups, QSP can also be considered as the most adapted tool to:
Evaluate
the likely magnitude of therapeutic effect vs. toxicity (Therapeutic Index)
Determine
efficacy in specific patient sub-populations (Patient Stratification and Personalized Medicine)
Support
the rationale for combination therapies or new indications.
