ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population. EMA/CPMP/ICH/2711/1999. Step 5. 

Published by European Medicines Agency

Paediatric Medicinal Product DevelopmentPaediatric FormulationPharmacokinetic

This document describes that paediatric drug development has evolved since the original ICH E11 Guideline (2000), requiring consideration of regulatory and scientific advances relevant to pediatric populations. This addendum does not alter the scope of the original guideline which outlines an approach to the safe, efficient, and ethical study of medicinal products in the pediatric population.

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