Skip to content

FIH dose exploration

This use case models first-in-human dose exploration using a population PK model with covariates.

Purpose: - Provide a realistic, reproducible workflow that maps to day-to-day PK decision making. - Validate deterministic execution and artifact replay under a practical scenario.

Model: - One-compartment IV bolus PK - Parameters: CL, V - Covariates: - WT on CL via power model exponent 0.75 (ref 70 kg) - WT on V via power model exponent 1.0 (ref 70 kg)

Population: - Cohort weights: fixed list, deterministic - IIV: log-normal on CL and V - Seeded RNG

Scenarios: - Dose levels: 10 mg, 30 mg, 100 mg, 300 mg (single dose)

Outputs: - Concentration time series per individual - Summary: mean, median, p05, p95 - Exposure metrics from mean curve: Cmax, AUC0-24

Validation: - Artifacts generated by run.jl must replay exactly. - Stored expected artifacts are compared via golden-style validation.