Module232025

12/05/2025

Modelling and Simulation – a quantitative tool

Key Messages:

M&S is a tool. It makes predictions (PK, PD) based on existing knowledge. This informs paediatric dosing in CT, sampling schemes and sample size Integration of emerging data into the model will increase accuracy of predictions and usefulness for clinical research M&S should always be used to inform paediatric clinical drug development

PBPK Modeling

Exploratory dose finding

Confirmatory trial safety and/efficacy

Exposure-Response Modeling Trial Simulations PBPK Modeling

Modeling to strengthen Dosing justification

From Reigner et al., Guide to Paediatric Drug Development and Clinical Research, Karger, 2010

Filing

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Section 4 Paediatric Studies

Sample Size

Considerations for long term follow-up

Key evaluations and outcome

Choice of control

For each study

Population to be included

Study design

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