title: Amikacin maturation model as a marker of renal maturation to predict glomerular filtration rate and vancomycin clearance in neonates.
abstract: OBJECTIVE
  Amikacin clearance has recently been proposed as a marker of renal maturation in neonates. However, the predictive value of this marker is still unknown. The objective of the present exploratory study was to evaluate the predictive performance of renal maturation model derived from amikacin to predict the glomerular filtration rate (GFR) and vancomycin clearance in neonates.
  
  
  METHODS
  The GFR and vancomycin clearance in neonates were predicted using a maturation model derived from amikacin via estimation and simulation in a cohort of 116 neonates using non-linear mixed-effects modeling NONMEM® software.
  
  
  RESULTS
  Our results demonstrate good correlations between predicted and observed GFR and vancomycin clearance in neonates. The square of the correlation coefficient, and means of the prediction error (2.5th-97.5th percentiles) and absolute prediction error (2.5th-97.5th percentiles) are 0.96, 1.2 % (-39.7 to 30.0 %) and 12.3 % (0.4-39.7 %), respectively, for GFR, and 0.97, -11.3 % (-38.2 to 15.4 %) and 14.0 % (0.5-38.2 %), respectively, for vancomycin. The prediction error is not significantly correlated with age.
  
  
  CONCLUSIONS
  An amikacin maturation model can precisely reflect maturation of glomerular filtration and thus predict the dosage regimens of other renally excreted drugs by glomerular filtration in neonates.
authors.affiliation: Department of Pediatric Pharmacology and Pharmacogenetics, Hôpital Robert Debré, APHP, Clinical Investigation Center CIC9202, INSERM, 48 Boulevard Sérurier, 75935, Paris Cedex 19, France, wei.zhao@rdb.aphp.fr.
authors.forename: Wei
authors.initials: W
authors.lastname: Zhao
authors.forename: Valérie
authors.initials: V
authors.lastname: Biran
authors.forename: Evelyne
authors.initials: E
authors.lastname: Jacqz-Aigrain
mesh_terms: D000583:Amikacin / Q000493:pharmacokinetics*; D000900:Anti-Bacterial Agents / Q000493:pharmacokinetics*; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007668:Kidney / Q000502:physiology*; D008297:Male; D008954:Models, Biological; D014640:Vancomycin / Q000493:pharmacokinetics
chemical_list: D000900:Anti-Bacterial Agents; D014640:Vancomycin; D000583:Amikacin
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