title: Neonatal drug trials: impact of EU and US paediatric regulations.
authors.affiliation: Service de Pharmacologie Pédiatrique, AP-HP, Hôpital Robert Debré, Paris, France Laboratory for Mother and Child Health, Department of Public Health, IRCCS Istituto di Ricerche Farmacologiche 'Mario Negri', Milan, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Pansieri
authors.affiliation: Laboratory for Mother and Child Health, Department of Public Health, IRCCS Istituto di Ricerche Farmacologiche 'Mario Negri', Milan, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Bonati
authors.affiliation: Academic Division of Child Health, Derbyshire Children's Hospital, University of Nottingham, Derby, UK.
authors.forename: Imti
authors.initials: I
authors.lastname: Choonara
authors.affiliation: Service de Pharmacologie Pédiatrique, AP-HP, Hôpital Robert Debré, Paris, France Université Paris Diderot, Sorbonne Paris Cité, Paris, France INSERM, CIC1426, Hôpital Robert Debré, Paris, France.
authors.forename: Evelyne
authors.initials: E
authors.lastname: Jacqz-Aigrain
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D004341:Drug Evaluation / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence; D005062:European Union; D006801:Humans; D007231:Infant, Newborn; D009359:Neonatology / Q000331:legislation & jurisprudence*; D014481:United States
keywords: Neonatology; Pharmacology