Impact of liver immaturity when investigating medicinal products intended for neonatal use

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Concept paper

Reference numberEMEA/CHMP/PEG/194605/05
KeywordsNeonates, medicines, developmental pharmacology, drug metabolising enzymes, maturational changes, immaturity
DescriptionThis document describes the issues relating to the immature capacity of neonates for metabolising and eliminating drugs by the liver.

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