Limited sampling model for area-under-the-curve monitoring in pediatric patients receiving either Sandimmune® or Neoral® cyclosporin A oral formulations

: Several limited sampling equations were tested to predict the area under the curve (AUC) of cyclosporin A (CsA) at steady state in 10 children with end‐stage renal disease receiving oral CsA 2.5 mg/kg b.i.d. as two different formulations, namely Sandimmune® and Neoral®, according to a randomized c...

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Bibliographic Details
Published in:Pediatric transplantation 1999-08, Vol.3 (3), p.225-230
Main Authors: Medeiros, M, Pérez-urizar, J, Muñoz, Ar, Castañeda-hernández, G
Format: Article
Language:English
Subjects:
Administration, Oral
Adolescent
Age Factors
Biological and medical sciences
Child
Child, Preschool
Cross-Over Studies
Cyclosporine - administration & dosage
Cyclosporine - pharmacokinetics
Data Interpretation, Statistical
Drug Monitoring
Humans
Immunomodulators
Immunosuppressive Agents - administration & dosage
Immunosuppressive Agents - pharmacokinetics
Kidney Transplantation
Linear Models
Medical sciences
Models, Theoretical
Neoral - Sandimmune - area under the curve - pharmacokinetics
Pharmacology. Drug treatments
Time Factors
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Summary:: Several limited sampling equations were tested to predict the area under the curve (AUC) of cyclosporin A (CsA) at steady state in 10 children with end‐stage renal disease receiving oral CsA 2.5 mg/kg b.i.d. as two different formulations, namely Sandimmune® and Neoral®, according to a randomized crossover design with a one‐month washout period. AUC was significantly correlated with CsA concentration at 5 h. The equation derived from this single concentration–time point was able to adequately predict the AUC for Sandimmune but not for Neoral. The equation derived from CsA concentration data, measured at 2 and 12 h, significantly improved predictive performance in terms of bias and precision, allowing adequate AUC predictions in both formulations. CsA concentration at 2 h was also able to predict Cmax, while the concentration at 12 h corresponded to the trough value in a b.i.d. dosing scheme. Therefore, it is concluded that a limited sampling model including concentration data at 2 and 12 h allows the estimation of AUC, Cmax and trough levels, yielding a complete profile in patients exposed to CsA as Sandimmune or Neoral. Hence, this model can be used for therapeutic monitoring of CsA levels in pediatric patients being switched from one formulation to another.
ISSN:1397-3142
1399-3046
DOI:10.1034/j.1399-3046.1999.00037.x