Module232025

5/7/2025

ICH E11 Guideline on Clinical Investigation of Medicinal Products in the Pediatric Population defines pediatric extrapolation as: “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” Paediatric extrapolation can extend what is known about the reference population (e.g., efficacy, safety, and/or dosing) to the target population based on an assessment of the relevant similarities of disease and response to therapy of the two populations Utility • Ethical imperative to consider its appropriate application  Prevent children from being enrolled in unnecessary trials • Optimize and increase efficiency of paediatric product development  Aid in decreasing the gap between initial adult approval and incorporation of paediatric-specific information in the label • Speed access to new drugs for paediatric patients • Feasibility, by itself, is not a scientific justification for use of extrapolation

Paediatric extrapolation

25

What is extrapolation

26

26

13