Module232025

09/05/2025

Introduction

› Use model(s) to simulate for example › Different doses, posologies

› Different study designs (run-in or not, times of visits, samplings) › Different ages, weights, degree of maturation of certain processes › Complete PK and/or PD profiles in time › Cascade of events › Disease progressions › Impact of covariates on PK, PD, clinical outcomes › … › Whatever you need as long as an adequate model is built and qualified for that context of use

The Organisation for Professionals in Regulatory Affairs

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Pediatric Extrapolation An approach to providing evidence in support of effective and safe use of drugs in the pediatric population when it can be assumed that the course of the disease and the expected response to a medicinal product would be sufficiently similar in the pediatric [target] and reference (adult or other pediatric) population

• Can apply to safety in addition to efficacy

ICH E11 A Guidelineon pediatricextrapolation step 5 framework for using extrapolation as a tool to support pediatric drug development • FDA https://www.fda.gov/media/161190/download (Dec 2024) • EMA https://www.ema.europa.eu/en/documents/scientific-guideline/ich guideline-e11a-pediatric-extrapolation-step-5_en.pdf (Jan2025)

The Organisation for Professionals in Regulatory Affairs

12