The clinical applications of renal ontogeny mainly include renal function evaluation and optimal dosing of renally eliminated drugs in pediatric patients, which rely on pharmacometric models and/or bedside estimated glomerular filtration rate equations. However, these applications in drug development are based on an understanding of renal function development, especially when considering premature infants, and the renal biomarkers that can be used for renal function assessment. This review provides a general overview on (1) renal function development, (2) the biomarkers that are used to assess renal function, and (3) the practical application of this knowledge to drug dosing for renally eliminated drugs during pediatric development. While pharmacometric approaches for estimating renal function during development have improved considerably, the number of drug development programs that have studied premature infants is small and suggests that caution should be taken in estimating doses for renally eliminated drugs during periods of rapid change in renal function.
Keywords: Biomarkers; Clinical Pharmacology; Neonatology; Nephrology; PBPK; Pediatrics; Pharmacometrics; Population Pharmacokinetics; Renal Disease.
© 2019, The American College of Clinical Pharmacology.