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.View this resource Bookmark this resource
This guideline addresses the considerations and requirements for the design and conduct of clinical trials in premature and term neonates using medicinal products of relevance for the use by this population. It includes background information on the maturation of organs and of body functions.View this resource Bookmark this resource
Committee for Medicinal Products for Human Use (CHMP) Role of pharmacokinetics in the development of medicinal products in the paediatric population 2006 Doc. Ref. EMEA/CHMP/EWP/147013/2004.
Published by European Medicines AgencyExtrapolationChildrenPharmacokineticsDose Finding AdolescentsNewbornsInfantsToddlers
This document focuses on preparedness for individual trials. However, as a development plan would normally constitute a number of trials, it is implicit that the same elements would also be relevant for preparation of a complete plan. Trial “feasibility” is the likelihood of completing a trial in a timely manner. This document moves beyond the definition of “feasibility” to present a global determination of all aspects of a trial that need to be