Covance Is Now Labcorp Drug Development

We are one global company innovating for millions – together, continuing to bring you more advanced medical breakthroughs.

Learn More

Quantitative Systems Pharmacology Modeling

Contact Us

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

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.

Let's start a conversation

Contact Us