Approaches to Dose Finding in Neonates, Illustrating the Variability between Neonatal Drug Development Programs

Off-label use of medicines in neonates, infants, children, and adolescents: a joint policy statement by the European Academy of Paediatrics and the European society for Developmental Perinatal and Pediatric Pharmacology

(2020) Lenneke Schrier et al.   EUROPEAN JOURNAL OF PEDIATRICS

Meropenem vs standard of care for treatment of neonatal late onset sepsis (NeoMero1): A randomised controlled trial

(2020) Irja Lutsar et al.   PLoS One

Ontogeny of ADME Processes during Postnatal Development in Man and Preclinical Species: A Comprehensive Review

(2019) Luc M. De Schaepdrijver et al.   DRUG METABOLISM AND DISPOSITION

Making Medicines Baby Size: The Challenges in Bridging the Formulation Gap in Neonatal Medicine

(2019) Fiona O’Brien et al.   INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES

Development of a physiologically-based pharmacokinetic pediatric brain model for prediction of cerebrospinal fluid drug concentrations and the influence of meningitis

(2019) Laurens F. M. Verscheijden et al.   PLoS Computational Biology

Ontogeny of Phase I Metabolism of Drugs

(2019) Karel Allegaert et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Drug Disposition and Pharmacotherapy in Neonatal ECMO: From Fragmented Data to Integrated Knowledge

(2019) Genny Raffaeli et al.   Frontiers in Pediatrics

Standardizing Safety Assessment and Reporting for Neonatal Clinical Trials

(2019) Jonathan M. Davis et al.   JOURNAL OF PEDIATRICS

Developmental pharmacogenetics of CYP2C19 in neonates and young infants: omeprazole as a probe drug

(2018) Wei Zhao et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Oxygen-Induced Retinopathy from Recurrent Intermittent Hypoxia Is Not Dependent on Resolution with Room Air or Oxygen, in Neonatal Rats

(2018) Kay Beharry et al.   INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES

Plasma and CSF pharmacokinetics of meropenem in neonates and young infants: results from the NeoMero studies

(2018) Eva Germovsek et al.   JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY

Developmental Changes in Pharmacokinetics and Pharmacodynamics

(2018) John van den Anker et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Variations in Neonatal Antibiotic Use

(2018) Joseph Schulman et al.   PEDIATRICS

Physiologically based pharmacokinetic (PBPK) modeling and simulation in neonatal drug development: how clinicians can contribute

(2018) Anne Smits et al.   Expert Opinion on Drug Metabolism & Toxicology

Evidence-based drug treatment for special patient populations through model-based approaches

(2017) Elke H.J. Krekels et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Caffeine Citrate Dosing Adjustments to Assure Stable Caffeine Concentrations in Preterm Neonates

(2017) Gilbert Koch et al.   JOURNAL OF PEDIATRICS

Adult hippocampal neurogenesis is impaired by transient and moderate developmental thyroid hormone disruption

(2017) M.E. Gilbert et al.   NEUROTOXICOLOGY

Pharmacometric Approaches to Personalize Use of Primarily Renally Eliminated Antibiotics in Preterm and Term Neonates

(2016) Mélanie Wilbaux et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates

(2016) Robert M. Ward et al.   PEDIATRIC RESEARCH

High variability in the dosing of commonly used antibiotics revealed by a Europe-wide point prevalence study: implications for research and dissemination

(2015) Tuuli Metsvaht et al.   BMC Pediatrics

Neonatal drug therapy: The first frontier of therapeutics for children

(2015) K Allegaert et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

In vitro anti-platelet potency of ticagrelor in blood samples from infants and children

(2015) Fredrik Söderlund et al.   THROMBOSIS RESEARCH

Dosing in neonates: special considerations in physiology and trial design

(2014) Lawrence C. Ku et al.   PEDIATRIC RESEARCH

Medication Use in the Neonatal Intensive Care Unit

(2013) Emily Hsieh et al.   AMERICAN JOURNAL OF PERINATOLOGY

Extrapolation of Hypothalamic-Pituitary-Thyroid Axis Perturbations and Associated Toxicity in Rodents to Humans: Case Study with Perchlorate

(2013) Jeffrey Fisher et al.   JOURNAL OF ENVIRONMENTAL SCIENCE AND HEALTH PART C-ENVIRONMENTAL CARCINOGENESIS & ECOTOXICOLOGY REVIEWS

Clopidogrel in Infants with Systemic-to-Pulmonary-Artery Shunts

(2013) David L. Wessel et al.   NEW ENGLAND JOURNAL OF MEDICINE

Neonatal clinical pharmacology

(2013) Karel Allegaert et al.   PEDIATRIC ANESTHESIA

Adverse Events Associated With Meropenem Versus Imipenem/Cilastatin Therapy in a Large Retrospective Cohort of Hospitalized Infants

(2013) Christoph P. Hornik et al.   PEDIATRIC INFECTIOUS DISEASE JOURNAL

A Neonatal Amikacin Covariate Model Can Be Used to Predict Ontogeny of Other Drugs Eliminated Through Glomerular Filtration in Neonates

(2013) Roosmarijn F. W. De Cock et al.   PHARMACEUTICAL RESEARCH

Evaluation of Iodide Deficiency in the Lactating Rat and Pup Using a Biologically Based Dose-Response Model*

(2013) Jeffrey W. Fisher et al.   TOXICOLOGICAL SCIENCES

Newborns, One of the Last Therapeutic Orphans to Be Adopted

(2013) Justin L. Stiers et al.   JAMA Pediatrics

Antithrombotic Therapy in Neonates and Children

(2012) Paul Monagle et al.   CHEST

Safety and Effectiveness of Meropenem in Infants With Suspected or Complicated Intra-abdominal Infections

(2012) M. Cohen-Wolkowiez et al.   CLINICAL INFECTIOUS DISEASES

Pharmacodynamic effects of clopidogrel in pediatric cardiac patients: A comparative study of platelet aggregation response

(2012) Lisa K. Jennings et al.   PLATELETS

Drug interaction of levothyroxine with infant colic drops

(2011) M. Balapatabendi et al.   ARCHIVES OF DISEASE IN CHILDHOOD

Population Pharmacokinetics of Meropenem in Plasma and Cerebrospinal Fluid of Infants With Suspected or Complicated Intra-abdominal Infections

(2011) P. Brian Smith et al.   PEDIATRIC INFECTIOUS DISEASE JOURNAL

Absorption of Levothyroxine When Coadministered with Various Calcium Formulations

(2011) Isabelle Zamfirescu et al.   THYROID

Significant Increase in Clopidogrel Use Across U.S. Children’s Hospitals

(2010) Chiara Gentilomo et al.   PEDIATRIC CARDIOLOGY

The Effect of Maternal Subclinical Hypothyroidism During Pregnancy on Brain Development in Rat Offspring

(2010) Dijie Liu et al.   THYROID

Role of Late Maternal Thyroid Hormones in Cerebral Cortex Development: An Experimental Model for Human Prematurity

(2009) P. Berbel et al.   CEREBRAL CORTEX

Dosing of Clopidogrel for Platelet Inhibition in Infants and Young Children

(2008) Jennifer S. Li et al.   CIRCULATION

Lower Thyroid Compensatory Reserve of Rat Pups after Maternal Hypothyroidism: Correlation of Thyroid, Hepatic, and Cerebrocortical Biomarkers with Hippocampal Neurophysiology

(2008) Matthew A. Taylor et al.   ENDOCRINOLOGY