ICH Clinical investigation of medicinal products in the paediatric population E11 (R1)

Published by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)ECRIN

Clinical Trials Toolkit

Provides an outline of critical issues in pediatric drug development and approaches to the safe, efficient, and ethical study of medicinal products in the pediatric population. The purpose of this addendum is to complement, provide clarification and current regulatory perspective on topics in pediatric drug development.

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ICH Clinical investigation of medicinal products in the paediatric population E11 (R1)

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