Module232025

12/05/2025

Extrapolation: a continuum

PIP submission: Scientific document

Modification(s) of the PIP (extrapolation plan) as necessary

Relevant PIP studies

https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bph.17396

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Extrapolation: Concept and plan

Understanding of the factors that can influence - disease - drug pharmacology - response to treatment - safety in both the reference and target population

The design of the study(ies) and/or analyses should reflect the similarities and differences, as well as the necessary information that needs to be collected to address the gaps in knowledge identified in the extrapolation concept.

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https://www.ema.europa.eu/en/ich-guideline-e11a-pediatric-extrapolation-scientific-guideline

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