Clinical investigation of medicinal products in the pediatric population – Addendum to ICH E11
- 17 October 2017
- clinical trial, drug development, extrapolation, formulation, ICH E11, modeling, pediatric formulation, pediatric population, simulation,
On 6 October 2017, the European Medicines Agency (EMA) published revised version of ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population in the form of an addendum. This document will become effective on 28 February 2018. Pediatric drug development has evolved since the original ICH E11 Guideline (2000), requiring consideration