This document proposes a framework for extrapolation of data from adults to children which could serve as a basis for regulatory decision making in planning and developing paediatric developments, including paediatric investigation plans.
Keywords: Paediatrics, extrapolation, medicine development, biostatistics, modelling and simulation
Current version
Adopted reflection paper on the use of extrapolation in the development of medicines for paediatrics - Revision 1
This document proposes a framework for extrapolation of data from adults to children which could serve as a basis for regulatory decision making in planning and developing paediatric developments, including paediatric investigation plans.
English (EN) (401.56 KB - PDF)
Document history
Adopted reflection paper on the use of extrapolation in the development of medicines for paediatrics - Revision 1
This document proposes a framework for extrapolation of data from adults to children which could serve as a basis for regulatory decision making in planning and developing paediatric developments, including paediatric investigation plans.
English (EN) (401.56 KB - PDF)
Overview of comments received on ' Reflection paper on the use of extrapolation in the development of medicines for paediatrics ' (EMA/189724/2018) - Revision 1
English (EN) (910.46 KB - PDF)
Draft reflection paper on the use of extrapolation in the development of medicines for paediatrics - Revision 1
English (EN) (226.55 KB - PDF)
Draft reflection paper on extrapolation of efficacy and safety in paediatric medicine development - First version
English (EN) (206.56 KB - PDF)
Concept paper on extrapolation of efficacy and safety in medicine development
The concept paper is intended to discuss the need and possibility to develop a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine authorisation.
English (EN) (103.57 KB - PDF)
Related content
- Scientific guidelines: paediatrics
- Directive 2001/83/EC
- Extrapolation of efficacy and safety in medicine development
- ICH E6 (R1) Good clinical practice
- ICH E8 General considerations for clinical trials
- ICH E9 Statistical principles for clinical trials
- ICH E10 Choice of control group in clinical trials
- ICH E11 Clinical investigation of medicinal products in the paediatric population