ICH guideline E11A on pediatric extrapolation - Scientific guideline
HumanScientific guidelines
This guideline provides recommendations for harmonised approaches for paediatric extrapolation to support the development and authorisation of paediatric medicines. It provides a framework for using extrapolation as a tool to support paediatric drug development that encompasses an iterative process for understanding the existing information available, the gaps in information needed to inform development and ways to generate additional information when needed.
This guideline is to be read in conjunction with the ICH E11 guideline on clinical investigation of medicinal products in the paediatric population and the ICH E11(R1) addendum, both available on page ICH E11(R1) step 5 guideline on clinical investigation of medicinal products in the pediatric population - Scientific guideline. Furthermore, Applicants wishing to follow an extrapolation approach are suggested to look also at EMA’s Structured guidance on the use of extrapolation.
Keywords: Paediatric medicinal product development, children, adolescents, extrapolation, pharmacokinetic, modelling and simulation, statistics