ICH E11(R1) step 5 guideline on clinical investigation of medicinal products in the pediatric population

This document 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 and provide clarification and current regulatory perspective on topics in pediatric drug development.

Keywords: Paediatric medicinal product development, age categories, ethics, paediatric formulation, pharmacokinetic

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