Towards evidence-based dosing regimens in children on the basis of population pharmacokinetic pharmacodynamic modelling

Archives of Disease in Childhood

Volumn 99, Issue 3, 2014, Pages 267-272

  Admiraal, Rick ^a,b,c   Van Kesteren, Charlotte ^a,b   Boelens, Jaap Jan ^a   Bredius, Robbert G M ^b   Tibboel, Dick ^c   Knibbe, Catherijne A J ^a,c,d  

^a UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^b LEIDEN UNIVERSITY   (Netherlands)

^c LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^d SOPHIA CHILDREN S HOSPITAL   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

CHILD; PEDIATRICS; PK/PD; PKPD; POPULATION MODELING;

ALKYLATING AGENTS; AMIKACIN; ANALGESICS, OPIOID; ANTI-BACTERIAL AGENTS; BUSULFAN; CHILD; DOSE-RESPONSE RELATIONSHIP, DRUG; EVIDENCE-BASED MEDICINE; HUMANS; MODELS, BIOLOGICAL; MORPHINE; PEDIATRICS;

EID: 84894024419     PISSN: 00039888     EISSN: 14682044     Source Type: Journal    
DOI: 10.1136/archdischild-2013-303721     Document Type: Article

References (37)

1. Kimland E, Odlind V. Off-label drug use in pediatric patients. Clin Pharmacol Ther 2012;91: 796-801.
2. Johnson TN. The problems in scaling adult drug doses to children. Arch Dis Child 2008;93: 207-11.
3. Kearns GL, Abdel-Rahman SM, Alander SW, et al. Developmental pharmacology- drug disposition, action and therapy in infants and children. New Engl J Med Drug Ther 2003;349: 1157-67.
4. Ince I, De Wildt SN, Tibboel D, et al. Tailor-made drug treatment for children: creation of an infrastructure for data-sharing and population PK-PD modeling. Drug Discov Today 2009;14: 316-20.
5. Anderson BJ, Holford NHG. Understanding dosing: children are small adults, neonates are immature children. Arch Dis Child 2013;98: 737-44.
6. Danhof M, de Jongh J, De Lange ECM, et al. Mechanism-based pharmacokineticpharmacodynamic modeling: biophase distribution, receptor theory, and dynamical systems analysis. Annu Rev Pharmacol Toxicol 2007;47: 357-400.
7. Sheiner L. Learning versus confirming in clinical drug development. Clin Pharmacol Ther 1997;61: 275-91.
8. Danhof M, de Lange ECM, Della Pasqua OE, et al. Mechanism-based pharmacokineticpharmacodynamic (PK-PD) modeling in translational drug research. Trends Pharmacol Sci 2008;29: 186-91.
9. Knibbe CAJ, Danhof M. Individualized dosing regimens in children based on population PKPD modelling: are we ready for it? Int J Pharm 2011;415: 9-14.
10. Knibbe CAJ, Krekels EHJ, Danhof M. Advances in paediatric pharmacokinetics. Expert Opin Drug Metab Toxicol 2011;7: 1-8.
11. De Cock RFW, Piana C, Krekels EHJ, et al. The role of population PK-PD modelling in paediatric clinical research. Eur J Clin Pharmacol 2011;67(Suppl 1): 5-16.
12. Sheiner LB, Rosenberg B, Marathe VV. Estimation of population characteristics of pharmacokinetic parameters from routine clinical data. J Pharmacokinet Biopharmacology 1977;5: 445-79.
13. Aarons L, Ogungbenro K. Optimal design of pharmacokinetic studies. Basic Clin Pharmacol Toxicol 2010;106: 250-5.
14. Johnson TN. Modelling approaches to dose estimation in children. Br J Clin Pharmacol 2005;59: 663-9.
15. Krekels EHJ, van Hasselt JGC, Tibboel D, et al. Systematic evaluation of the descriptive and predictive performance of paediatric morphine population models. Pharm Res 2011;28: 797-811.
16. Bergstrand M, Hooker AC, Wallin JE, et al. Prediction-corrected visual predictive checks for diagnosing nonlinear mixed-effects models. AAPS J 2011;13: 143-51.
17. Comets E, Brendel K, Mentré F. Computing normalised prediction distribution errors to evaluate nonlinear mixed-effect models: the npde add-on package for R. Comput Methods Programs Biomed 2008;90: 154-66.
18. De Cock RFW, Allegaert K, Schreuder MF, et al. Maturation of the glomerular filtration rate in neonates, as reflected by amikacin clearance. Clin Pharmacokinet 2012;51: 105-17.
19. American Academy of Pediatrics. Red Book: Report of the Committee on Infectious Diseases. 28th edn. American Academy of Pediatrics, 2009.
20. Knibbe CAJ, Krekels EHJ, van den Anker JN, et al. Morphine glucuronidation in preterm neonates, infants and children younger than 3 years. Clin Pharmacokinet 2009;48: 371-85.
21. Krekels EHJ, De Jongh J, van Lingen RA, et al. Predictive performance of a recently developed population pharmacokinetic model for morphine and its metabolites in new datasets of ( preterm) neonates, infants and children. Clin Pharmacokinet 2011;50: 51-63.
22. Ceelie I, de Wildt SN, van Dijk M, et al. Effect of intravenous paracetamol on postoperative morphine requirements in neonates and infants undergoing major noncardiac surgery a randomized controlled rrial. JAMA 2013;309: 149-54.
23. Bartelink IH, Boelens JJ, Bredius RGM, et al. Body weight-dependent pharmacokinetics of busulfan in paediatric haematopoietic stem cell transplantation patients: towards individualized dosing. Clin Pharmacokinet 2012;51: 331-45.
24. Bartelink IH, Wolfs T, Jonker M, et al. Highly variable plasma concentrations of voriconazole in pediatric hematopoietic stem cell transplantation patients. Antimicrob Agents Chemother 2013;57: 235-40.
25. Wallin JE, Friberg LE, Fasth A, et al. Population pharmacokinetics of tacrolimus in pediatric hematopoietic stem cell transplant recipients : new initial dosage suggestions and a model-based dosage adjustment tool. Therapeutic Drug Monitoring 2009;31: 457-66.
26. Bartelink IH, Bredius RGM, Belitser SV, et al. Association between busulfan exposure and outcome in children receiving intravenous busulfan before hematologic stem cell transplantation. Biol Blood Marrow Transplant 2009;15: 231-41.
27. Bartelink IH, van Kesteren C, Boelens JJ, et al. Predictive performance of a busulfan pharmacokinetic model in children and young adults. Ther Drug Monit 2012; 34: 574-83.
28. Johnson TN, Rostami-Hodjegan A, Tucker GT. Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children. Clin Pharmacokinet 2006;45: 931-56.
29. Krekels EHJ, Johnson TN, den Hoedt SM, et al. From Pediatric Covariate Model to Semiphysiological Function for Maturation: Part II-Sensitivity to Physiological and Physicochemical Properties. CPT pharmacometrics Syst Pharmacol 2012;1:e10.
30. Krekels EHJ, Neely M, Panoilia E, et al. From pediatric covariate model to semiphysiological function for maturation: part I-extrapolation of a covariate model from morphine to Zidovudine. CPT Pharmacometrics Syst Pharmacol 2012;1:e9.
31. Zhao W, Biran V, Jacqz-Aigrain E. Amikacin maturation model as a marker of renal maturation to predict glomerular filtration rate and vancomycin clearance in neonates. Clin Pharmacokinet 2013;52: 1127-34.
32. De Cock R, Allegaert K, Sherwin C, et al. A neonatal amikacin covariate model can be used to predict ontogeny of other drugs eliminated through glomerular filtration in neonates. Pharm Res 2013, in press.
33. Van Dijk M, Ceelie I, Tibboel D. Endpoints in pediatric pain studies. Eur J Clin Pharmacol 2011;67(Suppl 1): 61-6.
34. Langhendries JP, Battisti O, Bertrand JM, et al. Adaptation in neonatology of the once-daily concept of aminoglycoside administration: evaluation of a dosing chart for amikacin in an intensive care unit. Biol Neonate 1998;74: 351-62.
35. Sherwin CMT, Svahn S, Van der Linden A, et al. Individualised dosing of amikacin in neonates: a pharmacokinetic/pharmacodynamic analysis. Eur J Clin Pharmacol 2009;65: 705-13.
36. Young TE, Magnum B. Neofax 2010. 23 edn. Thomson Reuters, 2010.
37. Paediatric Formulary Committee. British National Formulary for Children: 2009. London: BMJ Group, 2009.