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Quantitative and/or systems pharmacology (QSP/SP) modeling

Quantitative and/or systems pharmacology (QSP/SP) modeling

A QSP/SP model can be used for justification of first-in-human (FIH) dosing, proof-of-concept (PoC®) study design and patient stratification. QSP/SP models are frequently used to support the development of large and small molecules with novel/multiple mechanisms. 

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 (PK), systems pharmacology is conducted using ordinary differential equations (ODEs) that interact with existing PK models to better predict clinical trials. 

QSP/SP modeling is not specifically required in regulatory guidance, but e.g., the FDA has strongly suggested including modeling in your data package upon submission.

Molecule or Product Type

Small Molecule, Biologics

Regulatory

FIH, IND & CTA

Industry Market

Pharma, Device