A number of barriers and challenges must be overcome in order to conduct the pharmacokinetic studies that are urgently needed to inform the selection and dosing of medication in neonates. However, overcoming these barriers can be difficult. This review outlines the common barriers researchers are confronted with, including issues with ethics approval and consent, study design for pharmacokinetic studies and the ability to measure the drug concentrations in the blood samples obtained. Strategies to overcome these challenges are also proposed.
Keywords: biomedical; drug; ethics; modeling; neonate; pharmacokinetics; translational research.