While compartmental PK studies evaluate a drug's ADME properties between a number of interconnected and homogeneous compartments, compartmental PK modeling and analysis makes assumptions and develops mathematical models (even when experimental parameters have been altered) to describe and predict those drug's pharmacokinetics.
Compartmental PK Overview
- Describes mathematically how a drug moves through various compartments in the body.
- Predicts how a PK profile changes with altered doses or dose regimens.
- Informs study design optimization for the entire development cycle
- Can predict PK profiles in other species (including human) using scaling techniques.
Regulatory & Timing Suggestions
Compartmental PK modelling is not specifically required in regulatory guidance, but the FDA has strongly suggested including modeling in your data package upon submission.
Additional ways compartmental modeling has been used include regulatory submissions for FIH dose justification in support of dose regimen changes in the clinic and for assessment of potential impact from material lot changes.
This type of modeling can be conducted at any phase from preclinical PK studies into the clinic.
- Dose regimen design and optimization
- Interspecies scaling/Phase I FIH Exposure predictions
- Population factors impacting PK: Age, ethnicity, gene expression
- Formulation bridging/bioequivalence, lot difference assessment