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Unfortunately, both efficacy and safety are much more difficult to establish in neonates, resulting in very few drugs licensed for use in this vulnerable population. This review will focus on dose\u2010related adverse events in neonates. Besides the regulatory classification on seriousness, adverse event assessment includes aspects related to signal detection, causality, and severity. Disentangling confounders from truly dose\u2010related adverse drug events remains a major challenge, as illustrated for drug\u2010induced renal impairment, drug\u2010induced liver injury, and neurodevelopmental outcome. Causality assessment, using either routine tools (Naranjo algorithm, World Health Organization's Uppsala Monitoring Center causality tool) or a Naranjo algorithm tailored to neonates, still does not sufficiently and reliably document causality in neonates. Finally, very recently, a first neonatal severity\u2010grading tool for neonates has been developed. Following the development of advanced pharmacokinetic approaches and techniques to predict and assess drug exposure, additional efforts are needed to truly and fully assess dose adverse drug events. To further operationalize the recently developed tools on causality and severity, reference databases on a palette of biomarkers and outcome variables and their covariates are an obvious next step. These databases should subsequently be integrated in modeling efforts to truly explore safety outcome, including aspects associated with or caused by drug dose or exposure.<\/jats:p>","DOI":"10.1002\/jcph.1827","type":"journal-article","created":{"date-parts":[[2021,6,29]],"date-time":"2021-06-29T18:46:22Z","timestamp":1624992382000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Dose\u2010Related Adverse Drug Events in Neonates: Recognition and Assessment"],"prefix":"10.1002","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9921-5105","authenticated-orcid":false,"given":"Karel","family":"Allegaert","sequence":"first","affiliation":[{"name":"Department of Development and Regeneration KU Leuven  Leuven Belgium"},{"name":"Department of Pharmaceutical and Pharmacological Sciences KU Leuven  Leuven Belgium"},{"name":"Department of Hospital Pharmacy Erasmus MC University Medical Center  Rotterdam the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"van den Anker","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology Children's National Health Hospital  Washington DC USA"},{"name":"Pediatric Pharmacology and Pharmacometrics University Children's Hospital Basel (UKBB) University of Basel  Basel Switzerland"},{"name":"Intensive Care and Department of Pediatric Surgery Erasmus MC Sophia Children's Hospital  Rotterdam The 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