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.