PK/PD

Exposure–response • covariates • diagnostics • simulation-ready reporting

TipGoal

Demonstrate PK/PD modeling workflows that are transparent and reproducible, with clear diagnostics and clinically interpretable parameters.

Deliverables

Specifications / Notes

• PK/PD Model Notes / Spec

Programming

• PK/PD Modeling Program

Programs and Outputs (HTML)

• PK/PD Output Report

What you’ll find here

• Purpose: Concentration-time and exposure–response modeling examples
• Traceability: Raw/derived PK → modeling dataset → model → diagnostics → outputs
• Typical outputs: Parameter table, GOF plots, residual diagnostics, VPC (if applicable)

Core components (typical)

• Structural model: 1–2 compartment (as applicable)
• Variability: IIV + residual error model
• Covariates: Weight, renal/hepatic function, age, formulation, etc.
• Reporting: Diagnostics + interpretation + (optional) simulation scenarios

QC checklist

• Time alignment: Dosing, sampling, and units consistently handled
• BLQ handling: Documented approach and impact assessment
• Sensitivity: Alternative error/covariate forms where appropriate
• Reproducibility: Versioned runs and locked outputs