Module232025

09/05/2025

Introduction key concepts

General PK/PD model types (cont) Semi-mechanistic (middle out)

Some physiologic steps are simplifieddepending on model application Impliessome data fittingbut not for all compartment structures(e.g. in vivo release rates or transporter mediated efflux rates)

PopulationPK/PD (top-down) Mathematical model developedby data fitting Define mathematical model that describes the data Estimate parameters and variability Assess model fit Explore what explains variability Assess if model fit improved based on statistical criteria

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Introduction key concepts

Output and use of different model types

Software examples

Model Type

What is the output?

Use and Applications

Understand drug ADME Predict the pharmacokinetics Can be used as basis for simulation (evaluate the impact of intrinsic and extrinsic factors) When model adequately qualified it can be used for simulation for future trials or entire phases and to guide formulation design and optimization

PBPK

GastroPlus ® PKSim ® SimCyp ®

Physiological model for specific product

Nonmem® PUMAS®

Semi mechanistic PK

Parameters describing drug properties (ADME)

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