Investigation of medicinal products in the term and preterm neonate

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Current effective version

Adopted guideline

Reference numberEMEA/536810/08
Published25/06/2009
Effective from01/01/2010
KeywordsNeonate, clinical trials, ethics, adverse effects, maturation, immaturity
DescriptionThis 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.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline

In operation: 01/01/2010–present


Published: 25/06/2009


Published: 01/10/2007


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