Obesity Considerations in Pediatric Drug Development, 2016-2021.

Pediatric obesity is a global public health concern. Obesity-related physiological changes may affect the pharmacokinetics of drugs and lead to therapeutic failure or toxicities. An earlier review of pediatric drug development programs from 2007 to 2016 found that, of 89 programs listing obesity-related terms, only 4 (4%) products described pharmacokinetic changes associated with obesity.

Transplacental methadone exposure and risk of Neonatal Opioid Withdrawal Syndrome.

Study Objective: Neonatal opioid withdrawal syndrome (NOWS) is a condition that often occurs in neonates born to mothers who received methadone treatment for opioid use disorder during pregnancy. Early identification and treatment of infants at risk of NOWS may improve clinical outcomes. The purpose of this study was to evaluate whether maternal and umbilical cord plasma concentrations of methadone and its metabolite, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), could predict the need for NOWS treatment.

Pediatric Efficacy Extrapolation in Drug Development Submitted to the US Food and Drug Administration 2015-2020.

Pediatric extrapolation plays a key role in the availability of reliable pediatric use information in approved drug labeling. This review examined the use of pediatric extrapolation in studies submitted to the US Food and Drug Administration and assessed changes in extrapolation approaches over time. Pediatric studies of 125 drugs submitted to the US Food and Drug Administration that led to subsequent pediatric information in drug labeling between 2015 and 2020 were reviewed.

A Tribute to the Pioneers of Fetal Pharmacology.

Clinical pharmacology is a branch of the field of pharmacology that evolved following the recognition that the nature, duration, and intensity of drug action depend on both the intrinsic properties of the drug and an interaction with the host to whom the drug is given. Advances in drug development have placed highly specific and extremely potent therapeutic agents in the marketplace. While these advances have progressed rapidly in adult medicine, pediatric clinical pharmacology has not kept pace and until very recently has lagged behind the research and attention paid to the proper use of therapeutic and diagnostic drugs in adults.

The effect of ibuprofen and caffeine prophylaxis on retinopathy of prematurity.

Purpose: To determine whether prophylactic caffeine and ibuprofen, which have been shown to have vascular endothelial growth factor-modulating properties in other contexts, have a detectable effect on the incidence of severe retinopathy of prematurity (ROP) when administered in extremely low birth weight infants during the first 48 hours of life.

Methods: In this retrospective cohort study, the incidence and severity of ROP with respect to total exposure to caffeine and ibuprofen were assessed. The effect of oxygen exposure at 28 days' postnatal age (PNA) and 36 weeks' corrected gestational age (GA) was also studied.