Committee for Medicinal Products for Human Use (CHMP) and Paediatric Committee (PDCO). Guideline on The Investigation of Medicinal Products In The Term And Preterm Neonate. 2009 Doc. Ref. EMEA/536810/2008.

Published by European Medicines Agency

Clinical TrialsNeonateAdverse Effects

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.

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