Investigation of medicinal products in the term and preterm neonate - Scientific guideline

This document 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.

Keywords: Neonate, clinical trials, ethics, adverse effects, maturation, immaturity

Document history - Revision 1


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