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Quantitative and/or Systems Pharmacology (QSP/SP) is a modeling approach that integrates preclinical mechanistic evidence and physiological system models to investigate and predict drug response. A subdiscipline of pharmacokinetics, systems pharmacology is conducted using ordinary differential equations (ODE’s) that interact with existing PK models to better predict clinical trials.
Common Uses for QSP / SP Studies
- Biomarker identification and prediction
- Translational predictions (see Translational Biomarkers)
- Mechanism understanding
- Target dose predictions
- Preclinical experimental design
Regulatory Guidance & Timing
QSP/SP modeling is not specifically required in regulatory guidance, but the FDA has strongly suggested including modeling in your data package upon submission.
A QSP/SP model can be used for justification of first-in-human dosing, proof-of-concept study design and patient stratification. QSP/SP models are frequently used to help support large and small molecules with novel/multiple mechanisms.
QSP/SP studies typically occur anywhere from target identification to proof-of-concept.
