Effect of Kidney Function on Drug Kinetics and Dosing in Neonates, Infants, and Children

Clinical Pharmacokinetics

Volumn 54, Issue 12, 2015, Pages 1183-1204

  Rodieux, Frederique ^a   Wilbaux, Melanie ^a   van den Anker, Johannes N ^a,b,c   Pfister, Marc ^a,d  

^a UNIVERSITY CHILDREN S HOSPITAL   (Switzerland)

^b CHILDREN'S NATIONAL MEDICAL CENTER   (United States)

^c SOPHIA CHILDREN S HOSPITAL   (Netherlands)

^d Quantitative Solutions   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMIKACIN; AMINOGLYCOSIDE; ANTIVIRUS AGENT; CALCINEURIN INHIBITOR; CREATININE; CYSTATIN C; CYTOCHROME P450; CYTOSTATIC AGENT; DIPEPTIDYL CARBOXYPEPTIDASE; GLUCURONOSYLTRANSFERASE; NONSTEROID ANTIINFLAMMATORY AGENT; POLYPEPTIDE ANTIBIOTIC AGENT; ANTIINFECTIVE AGENT; BIOLOGICAL MARKER;

ACUTE KIDNEY FAILURE; AGE; BODY COMPOSITION; BODY WEIGHT; CASE STUDY; CHILD; CHRONIC KIDNEY DISEASE; CREATININE BLOOD LEVEL; DRUG ABSORPTION; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG EXPOSURE; DRUG LABELING; DRUG METABOLISM; DRUG RESPONSE; EXTRACELLULAR FLUID; GENDER; HEREDITY; HUMAN; INFANT; KIDNEY DEVELOPMENT; KIDNEY FUNCTION; KIDNEY TUBULE ABSORPTION; MATERNAL PLASMA; MUSCLE MASS; NEWBORN; PERINATAL PERIOD; PHARMACOGENETICS; PHARMACOKINETICS; PRIORITY JOURNAL; REVIEW; SAMPLING; TOTAL BODY WATER; URINARY EXCRETION; VOLUME OF DISTRIBUTION; ACUTE KIDNEY INJURY; BIOLOGICAL MODEL; KIDNEY; METABOLISM; PHYSIOLOGY; PROSPECTIVE STUDY;

ACUTE KIDNEY INJURY; AMIKACIN; ANTI-BACTERIAL AGENTS; BIOMARKERS; HUMANS; KIDNEY; MODELS, BIOLOGICAL; PHARMACOKINETICS; PROSPECTIVE STUDIES;

EID: 84948584134     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.1007/s40262-015-0298-7     Document Type: Review

References (335)

1. Cella M, Knibbe C, Danhof M, Della Pasqua O. What is the right dose for children? Br J Clin Pharmacol. 2010;70(4):597–603.
2. ‘t Jong GW, Vulto AG, de Hoog M, Schimmel KJ, Tibboel D, van den Anker JN. A survey of the use of off-label and unlicensed drugs in a Dutch children’s hospital. Pediatrics. 2001;108(5):1089–93.
3. Conroy S, McIntyre J. The use of unlicensed and off-label medicines in the neonate. Semin Fetal Neonatal Med. 2005;10(2):115–22.
4. Conroy S, McIntyre J, Choonara I, Stephenson T. Drug trials in children: problems and the way forward. Br J Clin Pharmacol. 2000;49(2):93–7.
5. Baer GR, Nelson RM. Ethical challenges in neonatal research: summary report of the ethics group of the newborn drug development initiative. Clin Ther. 2006;28(9):1399–407.
6. Schreiner MS. Paediatric clinical trials: redressing the imbalance. Nat Rev Drug Discov. 2003;2(12):949–61.
7. Friis-Hansen B. Water distribution in the foetus and newborn infant. Acta Paediatr Scand Suppl. 1983;305:7–11.
8. Fomon SJ, Nelson SE. Body composition of the male and female reference infants. Ann Rev Nutr. 2002;22:1–17.
9. Fomon SJ, Haschke F, Ziegler EE, Nelson SE. Body composition of reference children from birth to age 10 years. Am J Clin Nutr. 1982;35(5 Suppl):1169–75.
10. Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology: drug disposition, action, and therapy in infants and children. N Engl J Med. 2003;349(12):1157–67.
11. Blake MJ, Castro L, Leeder JS, Kearns GL. Ontogeny of drug metabolizing enzymes in the neonate. Semin Fetal Neonatal Med. 2005;10(2):123–38.
12. Allegaert K, Fanos V, van den Anker JN, Laer S. Perinatal pharmacology. BioMed Res Int. 2014;2014:101620.
13. Allegaert K, van den Anker JN. Clinical pharmacology in neonates: small size, huge variability. Neonatology. 2014;105(4):344–9.
14. Allegaert K, van de Velde M, van den Anker J. Neonatal clinical pharmacology. Paediatr Anaesth. 2014;24(1):30–8.
15. Bhimma R, Purswani MU, Kala U. Kidney disease in children and adolescents with perinatal HIV-1 infection. J Int AIDS Soc. 2013;16:18596.
16. Knijnenburg SL, Mulder RL, Schouten-Van Meeteren AY, Bokenkamp A, Blufpand H, van Dulmen-den Broeder E, et al. Early and late renal adverse effects after potentially nephrotoxic treatment for childhood cancer. Cochrane Database Syst Rev. 2013;10:CD008944.
17. Patzer L. Nephrotoxicity as a cause of acute kidney injury in children. Pediatr Nephrol. 2008;23(12):2159–73.
18. Pazhayattil GS, Shirali AC. Drug-induced impairment of renal function. Int J Nephrol Renovasc Dis. 2014;7:457–68.
19. Wood T, Thoresen M. Physiological responses to hypothermia. Semin Fetal Neonatal Med. 2015;20(2):87–96.
20. Wildschut ED, de Wildt SN, Mathot RA, Reiss IK, Tibboel D, Van den Anker J. Effect of hypothermia and extracorporeal life support on drug disposition in neonates. Sem Fetal Neonatal Med. 2013;18(1):23–7.
21. Wildschut ED, van Saet A, Pokorna P, Ahsman MJ, Van den Anker JN, Tibboel D. The impact of extracorporeal life support and hypothermia on drug disposition in critically ill infants and children. Pediatr Clin North Am. 2012;59(5):1183–204.
22. Treszl A, Toth-Heyn P, Kocsis I, Nobilis A, Schuler A, Tulassay T, et al. Interleukin genetic variants and the risk of renal failure in infants with infection. Pediatr Nephrol. 2002;17(9):713–7.
23. National Heart, Lung, and Blood Institute, National Institutes of Health, US Department of Health and Human Services. 2015. http://www.nhlbi.nih.gov/childrenandclinicalstudies/whyclinical.php. Accessed 17 June 2015.
24. Bechard LJ, Wroe E, Ellis K. Body composition and growth. In: Duggan CW, Watkins J B, Walker WA, editors. Nutrition in pediatrics: basic science, clinical applications. Hamilton: BC Decker Inc.; 2008. pp. 20–40.
25. de Wildt SN, Tibboel D, Leeder JS. Drug metabolism for the paediatrician. Arch Dis Child. 2014;99(12):1137–42.
26. Funk RS, Brown JT, Abdel-Rahman SM. Pediatric pharmacokinetics: human development and drug disposition. Pediatr Clin North Am. 2012;59(5):1001–16.
27. van den Anker JN, Schwab M, Kearns GL. Developmental pharmacokinetics. Handb Exp Pharmacol. 2011;205:51–75.
28. Rakhmanina NY, van den Anker JN. Pharmacological research in pediatrics: from neonates to adolescents. Adv Drug Deliv Rev. 2006;58(1):4–14.
29. Ilett KF, Tee LB, Reeves PT, Minchin RF. Metabolism of drugs and other xenobiotics in the gut lumen and wall. Pharmacol Ther. 1990;46(1):67–93.
30. Johnson TN, Thomson M. Intestinal metabolism and transport of drugs in children: the effects of age and disease. J Pediatr Gastroenterol Nutr. 2008;47(1):3–10.
31. Rowland IR. Factors affecting metabolic activity of the intestinal microflora. Drug Metab Rev. 1988;19(3–4):243–61.
32. Fernandez E, Perez R, Hernandez A, Tejada P, Arteta M, Ramos JT. Factors and mechanisms for pharmacokinetic differences between pediatric population and adults. Pharmaceutics. 2011;3(1):53–72.
33. Hines RN. Developmental expression of drug metabolizing enzymes: impact on disposition in neonates and young children. Int J Pharm. 2013;452(1–2):3–7.
34. Coulthard MG. Maturation of glomerular filtration in preterm and mature babies. Early Hum Dev. 1985;11(3–4):281–92.
35. Schwartz GJ, Brion LP, Spitzer A. The use of plasma creatinine concentration for estimating glomerular filtration rate in infants, children, and adolescents. Pediatr Clinic North Am. 1987;34(3):571–90.
36. Alcorn J, McNamara PJ. Ontogeny of hepatic and renal systemic clearance pathways in infants: part II. Clin Pharmacokinet. 2002;41(13):1077–94.
37. Chen N, Aleksa K, Woodland C, Rieder M, Koren G. Ontogeny of drug elimination by the human kidney. Pediatr Nephrol. 2006;21(2):160–8.
38. Alcorn J, McNamara PJ. Ontogeny of hepatic and renal systemic clearance pathways in infants: part I. Clinl Pharmacokinet. 2002;41(12):959–98.
39. Hayton WL. Maturation and growth of renal function: dosing renally cleared drugs in children. AAPS PharmSci. 2000;2(1):E3.
40. Akaoka K, White RH, Raafat F. Human glomerular growth during childhood: a morphometric study. J Pathol. 1994;173(3):261–8.
41. Goyal VK. Changes with age in the human kidney. Exp Gerontol. 1982;17(5):321–31.
42. van den Anker JN. Pharmacokinetics and renal function in preterm infants. Acta Paediatr. 1996;85(12):1393–9.
43. Alcorn J, McNamara PJ. Pharmacokinetics in the newborn. Adv Drug Deliv Rev. 2003;55(5):667–86.
44. Allegaert K, Anderson BJ, van den Anker JN, Vanhaesebrouck S, de Zegher F. Renal drug clearance in preterm neonates: relation to prenatal growth. Ther Drug Monit. 2007;29(3):284–91.
45. van den Anker JN, Hop WC, de Groot R, van der Heijden BJ, Broerse HM, Lindemans J, et al. Effects of prenatal exposure to betamethasone and indomethacin on the glomerular filtration rate in the preterm infant. Pediatr Res. 1994;36(5):578–81.
46. Weiss CF, Glazko AJ, Weston JK. Chloramphenicol in the newborn infant. A physiologic explanation of its toxicity when given in excessive doses. N Engl J Med. 1960;262:787–94.
47. Rho JM, Storey TW. Molecular ontogeny of major neurotransmitter receptor systems in the mammalian central nervous system: norepinephrine, dopamine, serotonin, acetylcholine, and glycine. J Child Neurol. 2001;16(4):271–80 (discussion 81).
48. Takahashi H, Ishikawa S, Nomoto S, Nishigaki Y, Ando F, Kashima T, et al. Developmental changes in pharmacokinetics and pharmacodynamics of warfarin enantiomers in Japanese children. Clin Pharmacol Ther. 2000;68(5):541–55.
49. Marshall JD, Kearns GL. Developmental pharmacodynamics of cyclosporine. Clin Pharmacol Ther. 1999;66(1):66–75.
50. Kauffman RE, Nelson MV. Effect of age on ibuprofen pharmacokinetics and antipyretic response. J Pediatr. 1992;121(6):969–73.
51. Johnson TN. The development of drug metabolising enzymes and their influence on the susceptibility to adverse drug reactions in children. Toxicology. 2003;192(1):37–48.
52. Laer S, Elshoff JP, Meibohm B, Weil J, Mir TS, Zhang W, et al. Development of a safe and effective pediatric dosing regimen for sotalol based on population pharmacokinetics and pharmacodynamics in children with supraventricular tachycardia. J Am Coll Cardiol. 2005;46(7):1322–30.
53. Fisher DM, O’Keeffe C, Stanski DR, Cronnelly R, Miller RD, Gregory GA. Pharmacokinetics and pharmacodynamics of d-tubocurarine in infants, children, and adults. Anesthesiology. 1982;57(3):203–8.
54. Stephenson T. How children’s responses to drugs differ from adults. Br J Clin Pharmacol. 2005;59(6):670–3.
55. Van Driest SL, McGregor TL. Pharmacogenetics in clinical pediatrics: challenges and strategies. Per Med. 2013;10(7):666–71.
56. Rogers HL, Bhattaram A, Zineh I, Gobburu J, Mathis M, Laughren TP, et al. CYP2D6 genotype information to guide pimozide treatment in adult and pediatric patients: basis for the U.S. Food and Drug Administration’s new dosing recommendations. J Clin Psychiatry. 2012;73(9):1187–90.
57. Biss TT, Avery PJ, Brandao LR, Chalmers EA, Williams MD, Grainger JD, et al. VKORC1 and CYP2C9 genotype and patient characteristics explain a large proportion of the variability in warfarin dose requirement among children. Blood. 2012;119(3):868–73.
58. de Wildt SN, van Schaik RH, Soldin OP, Soldin SJ, Brojeni PY, van der Heiden IP, et al. The interactions of age, genetics, and disease severity on tacrolimus dosing requirements after pediatric kidney and liver transplantation. Eur J Clin Pharmacol. 2011;67(12):1231–41.
59. Gijsen V, Mital S, van Schaik RH, Soldin OP, Soldin SJ, van der Heiden IP, et al. Age and CYP3A5 genotype affect tacrolimus dosing requirements after transplant in pediatric heart recipients. J Heart Lung Transplant. 2011;30(12):1352–9.
60. Stockmann C, Fassl B, Gaedigk R, Nkoy F, Uchida DA, Monson S, et al. Fluticasone propionate pharmacogenetics: CYP3A4*22 polymorphism and pediatric asthma control. J Pediatr. 2013;162(6):1222–7, 1227.e1–2.
61. Peters U, Preisler-Adams S, Hebeisen A, Hahn M, Seifert E, Lanvers C, et al. Glutathione S-transferase genetic polymorphisms and individual sensitivity to the ototoxic effect of cisplatin. Anticancer Drugs. 2000;11(8):639–43.
62. Oldenburg J, Kraggerud SM, Cvancarova M, Lothe RA, Fossa SD. Cisplatin-induced long-term hearing impairment is associated with specific glutathione s-transferase genotypes in testicular cancer survivors. J Clin Oncol. 2007;25(6):708–14.
63. Wang L, Weinshilboum R. Thiopurine S-methyltransferase pharmacogenetics: insights, challenges and future directions. Oncogene. 2006;25(11):1629–38.
64. Adam de Beaumais T, Jacqz-Aigrain E. Pharmacogenetic determinants of mercaptopurine disposition in children with acute lymphoblastic leukemia. Eur J Clin Parmacol. 2012;68(9):1233–42.
65. Relling MV, Gardner EE, Sandborn WJ, Schmiegelow K, Pui CH, Yee SW, et al. Clinical pharmacogenetics implementation consortium guidelines for thiopurine methyltransferase genotype and thiopurine dosing: 2013 update. Clin Pharmacol Ther. 2013;93(4):324–5.
66. Chong KW, Chan DW, Cheung YB, Ching LK, Hie SL, Thomas T, et al. Association of carbamazepine-induced severe cutaneous drug reactions and HLA-B*1502 allele status, and dose and treatment duration in paediatric neurology patients in Singapore. Arch Dis Child. 2014;99(6):581–4.
67. Ganesan S, Hussain N. Question 2: Should phenytoin and carbamazepine be avoided in Asian populations with the HLA-B*1502 positive genetic variant? Arch Dis Child. 2011;96(1):104–6.
68. Chen P, Lin JJ, Lu CS, Ong CT, Hsieh PF, Yang CC, et al. Carbamazepine-induced toxic effects and HLA-B*1502 screening in Taiwan. N Engl J Med. 2011;364(12):1126–33.
69. Mercaptopurine. US National Library of Medicine. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c3b5b8b0-bc5c-4ce9-bbdc-febba60c265. Accessed 17 June 2015.
70. US National Library of Medicine. Imuran. Available at: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aaa6c540-4c84-48a0-939c-cd423134fa2a. Accessed 27 Feb 215.
71. Wei CY, Lee MT, Chen YT. Pharmacogenomics of adverse drug reactions: implementing personalized medicine. Hum Mol Genet. 2012;21(R1):R58–65.
72. US National Library of Medicine. Carbamazepine. Available at: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c13bc0b8-7900-4ef4-98ed-e1315a08d95d. Accessed 27 Feb 2015.
73. US National Library of Medicine. Stattera. 2015. Available at: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=309de576-c318-404a-bc15-660c2b1876fb. Accessed 27 Feb 2015.
74. Shaw K, Amstutz U, Hildebrand C, Rassekh SR, Hosking M, Neville K, et al. VKORC1 and CYP2C9 genotypes are predictors of warfarin-related outcomes in children. Pediatr Blood Cancer. 2014;61(6):1055–62.
75. Vear SI, Ayers GD, Van Driest SL, Sidonio RF, Stein CM, Ho RH. The impact of age and CYP2C9 and VKORC1 variants on stable warfarin dose in the paediatric population. Br J Haematol. 2014;165(6):832–5.
76. Benders MJ, Van Bel F, Van de Bor M. Cardiac output and ductal reopening during phototherapy in preterm infants. Acta Paediatr. 1999;88(9):1014–9.
77. Benders MJ, van Bel F, van de Bor M. Haemodynamic consequences of phototherapy in term infants. Eur J Pediatr. 1999;158(4):323–8.
78. Ardissino G, Dacco V, Testa S, Bonaudo R, Claris-Appiani A, Taioli E, et al. Epidemiology of chronic renal failure in children: data from the ItalKid project. Pediatrics. 2003;111(4 Pt 1):e382–7.
79. Chan JC, Williams DM, Roth KS. Kidney failure in infants and children. Pediatr Rev. 2002;23(2):47–60.
80. Ardissino G, Dacco V, Testa S, Bonaudo R, Claris-Appiani A, Taioli E, et al. Epidemiology of chronic renal failure in children: data from the ItalKid project. Pediatrics. 2003;111(4 Pt 1):e382–7.
81. Wong CJ, Moxey-Mims M, Jerry-Fluker J, Warady BA, Furth SL. CKiD (CKD in children) prospective cohort study: a review of current findings. Am J Kidney Dis. 2012;60(6):1002–11.
82. Medina Villanueva A, Lopez-Herce Cid J, Lopez Fernandez Y, Anton Gamero M, Concha Torre A, Rey Galan C, et al. Acute renal failure in critically-ill children. A preliminary study [in Spanish]. An Pediatr (Barc). 2004;61(6):509–14.
83. Bailey D, Phan V, Litalien C, Ducruet T, Merouani A, Lacroix J, et al. Risk factors of acute renal failure in critically ill children: a prospective descriptive epidemiological study. Pediatr Crit Care Med. 2007;8(1):29–35.
84. Stapleton FB, Jones DP, Green RS. Acute renal failure in neonates: incidence, etiology and outcome. Pediatr Nephrol. 1987;1(3):314–20.
85. Allegaert K, Vanhole C, de Hoon J, Guignard JP, Tibboel D, Devlieger H, et al. Nonselective cyclo-oxygenase inhibitors and glomerular filtration rate in preterm neonates. Pediatr Nephrol. 2005;20(11):1557–61.
86. Faught LN, Greff MJ, Rieder MJ, Koren G. Drug-induced acute kidney injury in children. Br J Clin Pharmacol. doi:10.1111/bcp.12554(Epub 13 Nov 2014).
87. Mendoza SA. Nephrotoxic drugs. Pediatr Nephrol. 1988;2(4):466–76.
88. Misurac JM, Knoderer CA, Leiser JD, Nailescu C, Wilson AC, Andreoli SP. Nonsteroidal anti-inflammatory drugs are an important cause of acute kidney injury in children. J Pediatr. 2013;162(6):1153–9, 11599.e1.
89. Destache CJ. Aminoglycoside-induced nephrotoxicity—a focus on monitoring: a review of literature. J Pharm Pract. 2014;27(6):562–6.
90. Wargo KA, Edwards JD. Aminoglycoside-induced nephrotoxicity. J Pharm Pract. 2014;27(6):573–7.
91. Laurent G, Kishore BK, Tulkens PM. Aminoglycoside-induced renal phospholipidosis and nephrotoxicity. Biochem Pharmacol. 1990;40(11):2383–92.
92. Kacew S, Bergeron MG. Pathogenic factors in aminoglycoside-induced nephrotoxicity. Toxicol Lett. 1990;51(3):241–59 (discussion 37–9).
93. Plaut ME, Schentag JJ, Jusko WJ. Nephrotoxicity with gentamicin or tobramycin. Lancet. 1979;2(8141):526–7.
94. Moore RD, Smith CR, Lipsky JJ, Mellits ED, Lietman PS. Risk factors for nephrotoxicity in patients treated with aminoglycosides. Ann Intern Med. 1984;100(3):352–7.
95. Dahlager JI. The effect of netilmicin and other aminoglycosides on renal function. A survey of the literature on the nephrotoxicity of netilmicin. Scand J Infect Dis Suppl. 1980;Suppl 23:96–102.
96. McCracken GH Jr. Aminoglycoside toxicity in infants and children. Am J Med. 1986;80(6b):172–8.
97. Meyer RD. Risk factors and comparisons of clinical nephrotoxicity of aminoglycosides. Am J Med. 1986;80(6b):119–25.
98. McKamy S, Hernandez E, Jahng M, Moriwaki T, Deveikis A, Le J. Incidence and risk factors influencing the development of vancomycin nephrotoxicity in children. J Pediatr. 2011;158(3):422–6.
99. Ragab AR, Al-Mazroua MK, Al-Harony MA. Incidence and predisposing factors of vancomycin-induced nephrotoxicity in children. Infect Dis Ther. 2013;2(1):37–46.
100. Sinclair EA, Yenokyan G, McMunn A, Fadrowski JJ, Milstone AM, Lee CK. Factors associated with acute kidney injury in children receiving vancomycin. Ann Pharmacother. 2014;48(12):1555–62.
101. Chow AW, Azar RM. Glycopeptides and nephrotoxicity. Intensive Care Med. 1994;20(Suppl 4):S23–9.
102. Goldman RD, Koren G. Amphotericin B nephrotoxicity in children. J Pediatr Hematol Oncol. 2004;26(7):421–6.
103. Sabra R, Branch RA. Amphotericin B nephrotoxicity. Drug Saf. 1990;5(2):94–108.
104. Schreiber R, Wolpin J, Koren G. Determinants of aciclovir-induced nephrotoxicity in children. Paediatr Drugs. 2008;10(2):135–9.
105. Ahmad T, Simmonds M, McIver AG, McGraw ME. Reversible renal failure in renal transplant patients receiving oral acyclovir prophylaxis. Pediatr Nephrol. 1994;8(4):489–91.
106. Olowu WA, Adenowo OA, Elusiyan JB. Reversible renal failure in hypertensive idiopathic nephrotics treated with captopril. Saudi J Kidney Dis Transpl. 2006;17(2):216–21.
107. Hanevold CD. Acute renal failure during lisinopril and losartan therapy for proteinuria. Pharmacotherapy. 2006;26(9):1348–51.
108. Ojo AO, Held PJ, Port FK, Wolfe RA, Leichtman AB, Young EW, et al. Chronic renal failure after transplantation of a nonrenal organ. N Engl J Med. 2003;349(10):931–40.
109. Rudnick MR, Goldfarb S, Wexler L, Ludbrook PA, Murphy MJ, Halpern EF, et al. Nephrotoxicity of ionic and nonionic contrast media in 1196 patients: a randomized trial. The Iohexol Cooperative Study. Kidney Int. 1995;47(1):254–61.
110. Patzer L, Kentouche K, Ringelmann F, Misselwitz J. Renal function following hematological stem cell transplantation in childhood. Pediatr Nephrol. 2003;18(7):623–35.
111. Rossi R, Kleta R, Ehrich JH. Renal involvement in children with malignancies. Pediatr Nephrol. 1999;13(2):153–62.
112. Skinner R, Cotterill SJ, Stevens MC. Risk factors for nephrotoxicity after ifosfamide treatment in children: a UKCCSG Late Effects Group study. United Kingdom Children’s Cancer Study Group. Br J Cancer. 2000;82(10):1636–45.
113. Skinner R, Pearson AD, English MW, Price L, Wyllie RA, Coulthard MG, et al. Cisplatin dose rate as a risk factor for nephrotoxicity in children. Br J Cancer. 1998;77(10):1677–82.
114. Kintzel PE. Anticancer drug-induced kidney disorders. Drug Saf. 2001;24(1):19–38.
115. Moffett BS, Goldstein SL. Acute kidney injury and increasing nephrotoxic-medication exposure in noncritically-ill children. Clin J Am Soc Nephrol. 2011;6(4):856–63.
116. Collins AJ, Foley RN, Herzog C, Chavers BM, Gilbertson D, Ishani A, et al. Excerpts from the US Renal Data System 2009 Annual Data Report. Am J Kidney Dis. 2010;55(1 Suppl 1):S1-420, A6-7.
117. Pea F, Viale P, Pavan F, Furlanut M. Pharmacokinetic considerations for antimicrobial therapy in patients receiving renal replacement therapy. Clin Pharmacokinet. 2007;46(12):997–1038.
118. Veltri MA, Neu AM, Fivush BA, Parekh RS, Furth SL. Drug dosing during intermittent hemodialysis and continuous renal replacement therapy: special considerations in pediatric patients. Paediatr Drugs. 2004;6(1):45–65.
119. Keller F, Wilms H, Schultze G, Offerman G, Molzahn M. Effect of plasma protein binding, volume of distribution and molecular weight on the fraction of drugs eliminated by hemodialysis. Clin Nephrol. 1983;19(4):201–5.
120. Bohler J, Donauer J, Keller F. Pharmacokinetic principles during continuous renal replacement therapy: drugs and dosage. Kidney Int Suppl. 1999;72:S24–8.
121. Golper TA, Bennett WM. Drug removal by continuous arteriovenous haemofiltration. A review of the evidence in poisoned patients. Med Toxicol Adverse Drug Exp. 1988;3(5):341-9.
122. Reidenberg MM, Drayer DE. Drug therapy in renal failure. Ann Rev Pharmacol Toxicol. 1980;20:45–54.
123. Joy MS, Matzke GR, Armstrong DK, Marx MA, Zarowitz BJ. A primer on continuous renal replacement therapy for critically ill patients. Ann Pharmacother. 1998;32(3):362–75.
124. Reetze-Bonorden P, Bohler J, Keller E. Drug dosage in patients during continuous renal replacement therapy. Pharmacokinetic and therapeutic considerations. Clin Pharmacokinet. 1993;24(5):362–79.
125. Nobilis A, Kocsis I, Toth-Heyn P, Treszl A, Schuler A, Tulassay T, et al. Variance of ACE and AT1 receptor gene does not influence the risk of neonatal acute renal failure. Pediatr Nephrol. 2001;16(12):1063–6.
126. Harding D, Dhamrait S, Marlow N, Whitelaw A, Gupta S, Humphries S, et al. Angiotensin-converting enzyme DD genotype is associated with worse perinatal cardiorespiratory adaptation in preterm infants. J Pediatr. 2003;143(6):746–9.
127. Vasarhelyi B, Toth-Heyn P, Treszl A, Tulassay T. Genetic polymorphisms and risk for acute renal failure in preterm neonates. Pediatr Nephrol. 2005;20(2):132–5.
128. Padulles A, Rama I, Llaudo I, Lloberas N. Developments in renal pharmacogenomics and applications in chronic kidney disease. Pharmgenomics Pers Med. 2014;7:251–66.
129. Yang HY, Lu KC, Lee HS, Huang SM, Lin YF, Wu CC, et al. Role of the functional Toll-Like receptor-9 promoter polymorphism (-1237T/C) in increased risk of end-stage renal disease: a case-control study. PloS One. 2013;8(3):e58444.
130. Hawwa AF, McKiernan PJ, Shields M, Millership JS, Collier PS, McElnay JC. Influence of ABCB1 polymorphisms and haplotypes on tacrolimus nephrotoxicity and dosage requirements in children with liver transplant. Br J Clin Pharmacol. 2009;68(3):413–21.
131. Hart SN, Zhong XB. P450 oxidoreductase: genetic polymorphisms and implications for drug metabolism and toxicity. Expert Opin Drug Metab Toxicol. 2008;4(4):439–52.
132. Elens L, Hesselink DA, van Schaik RH, van Gelder T. The CYP3A4*22 allele affects the predictive value of a pharmacogenetic algorithm predicting tacrolimus predose concentrations. Br J Clin Pharmacol. 2013;75(6):1545–7.
133. Elens L, Bouamar R, Hesselink DA, Haufroid V, van der Heiden IP, van Gelder T, et al. A new functional CYP3A4 intron 6 polymorphism significantly affects tacrolimus pharmacokinetics in kidney transplant recipients. Clin Chem. 2011;57(11):1574–83.
134. Gijsen VM, van Schaik RH, Elens L, Soldin OP, Soldin SJ, Koren G, et al. CYP3A4*22 and CYP3A combined genotypes both correlate with tacrolimus disposition in pediatric heart transplant recipients. Pharmacogenomics. 2013;14(9):1027–36.
135. Elens L, Hesselink DA, Bouamar R, Budde K, de Fijter JW, De Meyer M, et al. Impact of POR*28 on the pharmacokinetics of tacrolimus and cyclosporine A in renal transplant patients. Ther Drug Monit. 2014;36(1):71–9.
136. de Jonge H, Metalidis C, Naesens M, Lambrechts D, Kuypers DR. The P450 oxidoreductase *28 SNP is associated with low initial tacrolimus exposure and increased dose requirements in CYP3A5-expressing renal recipients. Pharmacogenomics. 2011;12(9):1281–91.
137. Gijsen VM, van Schaik RH, Soldin OP, Soldin SJ, Nulman I, Koren G, et al. P450 oxidoreductase *28 (POR*28) and tacrolimus disposition in pediatric kidney transplant recipients: a pilot study. Ther Drug Monit. 2014;36(2):152–8.
138. Hesselink DA, Bouamar R, Elens L, van Schaik RH, van Gelder T. The role of pharmacogenetics in the disposition of and response to tacrolimus in solid organ transplantation. Clin Pharmacokinet. 2014;53(2):123–39.
139. Filipski KK, Mathijssen RH, Mikkelsen TS, Schinkel AH, Sparreboom A. Contribution of organic cation transporter 2 (OCT2) to cisplatin-induced nephrotoxicity. Clin Pharmacol Ther. 2009;86(4):396–402.
140. Hassan Y, Al-Ramahi R, Abd Aziz N, Ghazali R. Drug use and dosing in chronic kidney disease. Ann Acad Med Singap. 2009;38(12):1095–103.
141. Atkinson AJ Jr, Huang SM. Nephropharmacology: drugs and the kidney. Clin Pharmacol Ther. 2009;86(5):453–6.
142. Brater DC. Drug dosing in patients with impaired renal function. Clin Pharmacol Ther. 2009;86(5):483–9.
143. Naud J, Nolin TD, Leblond FA, Pichette V. Current understanding of drug disposition in kidney disease. J Clin Pharmacol. 2012;52(1 Suppl):10s–22s.
144. Joy MS. Impact of glomerular kidney diseases on the clearance of drugs. J Clin Pharmacol. 2012;52(1 Suppl):23s–34s.
145. Gabardi S, Abramson S. Drug dosing in chronic kidney disease. Med Clin North Am. 2005;89(3):649–87.
146. Kappel J, Calissi P. Nephrology: 3. Safe drug prescribing for patients with renal insufficiency. CMAJ. 2002;166(4):473–7.
147. Perazella MA, Parikh C. Pharmacology. Am J Kidney Dis. 2005;46(6):1129–39.
148. Nolin TD, Naud J, Leblond FA, Pichette V. Emerging evidence of the impact of kidney disease on drug metabolism and transport. Clin Pharmacol Ther. 2008;83(6):898–903.
149. Kober A, Sjöholm I, Borgå O, Odar-Cederlöf I. Protein binding of diazepam and digitoxin in uremic and normal serum. Biochem Pharmacol. 1979;28(7):1037–42.
150. Knights KM, Rowland A, Miners JO. Renal drug metabolism in humans: the potential for drug-endobiotic interactions involving cytochrome P450 (CYP) and UDP-glucuronosyltransferase (UGT). Br J Clin Pharmacol. 2013;76(4):587–602.
151. Mutsaers HA, Wilmer MJ, Reijnders D, Jansen J, van den Broek PH, Forkink M, et al. Uremic toxins inhibit renal metabolic capacity through interference with glucuronidation and mitochondrial respiration. Biochim Biophys Acta. 2013;1832(1):142–50.
152. Dreisbach AW, Lertora JJ. The effect of chronic renal failure on drug metabolism and transport. Expert Opin Drug Metab Toxicol. 2008;4(8):1065–74.
153. Naud J, Michaud J, Leblond FA, Lefrancois S, Bonnardeaux A, Pichette V. Effects of chronic renal failure on liver drug transporters. Drug Metab Dispos. 2008;36(1):124–8.
154. Yeung CK, Shen DD, Thummel KE, Himmelfarb J. Effects of chronic kidney disease and uremia on hepatic drug metabolism and transport. Kidney Int. 2014;85(3):522–8.
155. Leblond FA, Giroux L, Villeneuve JP, Pichette V. Decreased in vivo metabolism of drugs in chronic renal failure. Drug Metab Dispos. 2000;28(11):1317–20.
156. Tsujimoto M, Kinoshita Y, Hirata S, Otagiri M, Ohtani H, Sawada Y. Effects of uremic serum and uremic toxins on hepatic uptake of digoxin. Ther Drug Monit. 2008;30(5):576–82.
157. Klammt S, Wojak HJ, Mitzner A, Koball S, Rychly J, Reisinger EC, et al. Albumin-binding capacity (ABiC) is reduced in patients with chronic kidney disease along with an accumulation of protein-bound uraemic toxins. Nephrol Dial Transplant. 2012;27(6):2377–83.
158. Rosner MH, Bolton WK. Renal function testing. Am J Kidney Dis. 2006;47(1):174–83.
159. Stevens LA, Levey AS. Measurement of kidney function. Med Clin North Am. 2005;89(3):457–73.
160. 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(12):1127–34.
161. Stevens LA, Coresh J, Greene T, Levey AS. Assessing kidney function: measured and estimated glomerular filtration rate. N Engl J Med. 2006;354(23):2473–83.
162. Pierrat A, Gravier E, Saunders C, Caira MV, Ait-Djafer Z, Legras B, et al. Predicting GFR in children and adults: a comparison of the Cockcroft-Gault, Schwartz, and modification of diet in renal disease formulas. Kidney Int. 2003;64(4):1425–36.
163. Schwartz GJ, Haycock GB, Edelmann CM Jr, Spitzer A. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics. 1976;58(2):259–63.
164. Counahan R, Chantler C, Ghazali S, Kirkwood B, Rose F, Barratt TM. Estimation of glomerular filtration rate from plasma creatinine concentration in children. Arch Dis Child. 1976;51(11):875–8.
165. Leger F, Bouissou F, Coulais Y, Tafani M, Chatelut E. Estimation of glomerular filtration rate in children. Pediatr Nephrol. 2002;17(11):903–7.
166. Morris MC, Allanby CW, Toseland P, Haycock GB, Chantler C. Evaluation of a height/plasma creatinine formula in the measurement of glomerular filtration rate. Arch Dis Child. 1982;57(8):611–5.
167. Shull BC, Haughey D, Koup JR, Baliah T, Li PK. A useful method for predicting creatinine clearance in children. Clin Chem. 1978;24(7):1167–9.
168. Traub SL, Johnson CE. Comparison of methods of estimating creatinine clearance in children. Am J Hosp Pharm. 1980;37(2):195–201.
169. van den Anker JN, de Groot R, Broerse HM, Sauer PJ, van der Heijden BJ, Hop WC, et al. Assessment of glomerular filtration rate in preterm infants by serum creatinine: comparison with inulin clearance. Pediatrics. 1995;96(6):1156–8.
170. Dechaux M, Gonzalez G, Broyer M. Plasma creatinine, and clearance and urinary excretion of creatinine in children [in French]. Arch Fr Pediatr. 1978;35(1):53–62.
171. Doolan PD, Alpen EL, Theil GB. A clinical appraisal of the plasma concentration and endogenous clearance of creatinine. Am J Medi. 1962;32:65–79.
172. Fong J, Johnston S, Valentino T, Notterman D. Length/serum creatinine ratio does not predict measured creatinine clearance in critically ill children. Clin Pharmacol Ther. 1995;58(2):192–7.
173. Seikaly MG, Browne R, Bajaj G, Arant BS Jr. Limitations to body length/serum creatinine ratio as an estimate of glomerular filtration in children. Pediatr Nephrol. 1996;10(6):709–11.
174. Urakami Y, Kimura N, Okuda M, Masuda S, Katsura T, Inui K. Transcellular transport of creatinine in renal tubular epithelial cell line LLC-PK1. Drug Metab Pharmacokinet. 2005;20(3):200–5.
175. Lee CK, Swinford RD, Cerda RD, Portman RJ, Hwang W, Furth SL. Evaluation of serum creatinine concentration-based glomerular filtration rate equations in pediatric patients with chronic kidney disease. Pharmacotherapy. 2012;32(7):642–8.
176. Hogg RJ, Furth S, Lemley KV, Portman R, Schwartz GJ, Coresh J, et al. National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative clinical practice guidelines for chronic kidney disease in children and adolescents: evaluation, classification, and stratification. Pediatrics. 2003;111(6 Pt 1):1416–21.
177. Bueva A, Guignard JP. Renal function in preterm neonates. Pediatr Res. 1994;36(5):572–7.
178. Feldman H, Guignard JP. Plasma creatinine in the first month of life. Arch Dis Child. 1982;57(2):123–6.
179. Miall LS, Henderson MJ, Turner AJ, Brownlee KG, Brocklebank JT, Newell SJ, et al. Plasma creatinine rises dramatically in the first 48 hours of life in preterm infants. Pediatrics. 1999;104(6):e76.
180. Allegaert K, Pauwels S, Smits A, Crevecoeur K, van den Anker J, Mekahli D, et al. Enzymatic isotope dilution mass spectrometry (IDMS) traceable serum creatinine is preferable over Jaffe in neonates and young infants. Clin Chem Lab Med. 2014;52(6):e107–9.
181. Gallini F, Maggio L, Romagnoli C, Marrocco G, Tortorolo G. Progression of renal function in preterm neonates with gestational age < or = 32 weeks. Pediatr Nephrol. 2000;15(1–2):119–24.
182. Guignard JP, Drukker A. Why do newborn infants have a high plasma creatinine? Pediatrics. 1999;103(4):e49.
183. Matos P, Duarte-Silva M, Drukker A, Guignard JP. Creatinine reabsorption by the newborn rabbit kidney. Pediatr Res. 1998;44(5):639–41.
184. Wuyts B, Bernard D, Van den Noortgate N, Van de Walle J, Van Vlem B, De Smet R, et al. Reevaluation of formulas for predicting creatinine clearance in adults and children, using compensated creatinine methods. Clin Chem. 2003;49(6 Pt 1):1011–4.
185. Chan MH, Ng KF, Szeto CC, Lit LC, Chow KM, Leung CB, et al. Effect of a compensated Jaffe creatinine method on the estimation of glomerular filtration rate. Ann Clin Biochem. 2004;41(Pt 6):482–4.
186. Drion I, Cobbaert C, Groenier KH, Weykamp C, Bilo HJ, Wetzels JF, et al. Clinical evaluation of analytical variations in serum creatinine measurements: why laboratories should abandon Jaffe techniques. BMC Nephrol. 2012;13:133.
187. van den Anker JN. Renal function in preterm infants. Eur J Pediatr. 1997;156(7):583–4.
188. Miller WG, Myers GL, Ashwood ER, Killeen AA, Wang E, Thienpont LM, et al. Creatinine measurement: state of the art in accuracy and interlaboratory harmonization. Arch Pathol Lab Med. 2005;129(3):297–304.
189. Neuman G, Nulman I, Adeli K, Koren G, Colantonio DA, Hellden A. Implications of serum creatinine measurements on GFR estimation and vancomycin dosing in children. J Clin Pharmacol. 2014;54(7):785–91.
190. Myers GL, Miller WG, Coresh J, Fleming J, Greenberg N, Greene T, et al. Recommendations for improving serum creatinine measurement: a report from the Laboratory Working Group of the National Kidney Disease Education Program. Clin Chem. 2006;52(1):5–18.
191. Finney H, Newman DJ, Thakkar H, Fell JM, Price CP. Reference ranges for plasma cystatin C and creatinine measurements in premature infants, neonates, and older children. Arch Dis Child. 2000;82(1):71–5.
192. Harmoinen A, Ylinen E, Ala-Houhala M, Janas M, Kaila M, Kouri T. Reference intervals for cystatin C in pre- and full-term infants and children. Pediatr Nephrol. 2000;15(1–2):105–8.
193. Kandasamy Y, Smith R, Wright IM. Measuring cystatin C to determine renal function in neonates. Pediatr Crit Care Med. 2013;14(3):318–22.
194. Randers E, Erlandsen EJ. Serum cystatin C as an endogenous marker of the renal function: a review. Clin Chem Lab Med. 1999;37(4):389–95.
195. Brou NA, Jacqz-Aigrain E, Zhao W. Cystatin C as a potential biomarker for dosing of renally excreted drugs. Br J Clin Pharmacol. doi:10.1111/bcp.12602(Epub 5 Feb 2015).
196. Cataldi L, Mussap M, Bertelli L, Ruzzante N, Fanos V, Plebani M. Cystatin C in healthy women at term pregnancy and in their infant newborns: relationship between maternal and neonatal serum levels and reference values. Am J Perinatol. 1999;16(6):287–95.
197. Galteau MM, Guyon M, Gueguen R, Siest G. Determination of serum cystatin C: biological variation and reference values. Clin Chem Lab Med. 2001;39(9):850–7.
198. Martini S, Prevot A, Mosig D, Werner D, van Melle G, Guignard JP. Glomerular filtration rate: measure creatinine and height rather than cystatin C! Acta Paediatr. 2003;92(9):1052–7.
199. Marsenic O, Wierenga A, Wilson DR, Anderson M, Shrivastava T, Simon GA, et al. Cystatin C in children on chronic hemodialysis. Pediatr Nephrol. 2013;28(4):647–53.
200. Hoek FJ, Korevaar JC, Dekker FW, Boeschoten EW, Krediet RT. Estimation of residual glomerular filtration rate in dialysis patients from the plasma cystatin C level. Nephrol Dial Transplant. 2007;22(6):1633–8.
201. Kim SJ, Sohn YB, Park SW, Jin DK, Paik KH. Serum cystatin C for estimation of residual renal function in children on peritoneal dialysis. Pediatr Nephrol. 2011;26(3):433–40.
202. Filler G, Huang SH, Lindsay RM. Residual renal function assessment with cystatin C. Pediatr Nephrol. 2011;26(3):333–5.
203. Bolignano D, Donato V, Coppolino G, Campo S, Buemi A, Lacquaniti A, et al. Neutrophil gelatinase-associated lipocalin (NGAL) as a marker of kidney damage. Am J Kidney Dis. 2008;52(3):595–605.
204. Bolignano D, Lacquaniti A, Coppolino G, Donato V, Campo S, Fazio MR, et al. Neutrophil gelatinase-associated lipocalin (NGAL) and progression of chronic kidney disease. Clin J Am Soc Nephrol. 2009;4(2):337–44.
205. Clerico A, Galli C, Fortunato A, Ronco C. Neutrophil gelatinase-associated lipocalin (NGAL) as biomarker of acute kidney injury: a review of the laboratory characteristics and clinical evidences. Clin Chem Lab Med. 2012;50(9):1505–17.
206. de Geus HR, Betjes MG, Bakker J. Biomarkers for the prediction of acute kidney injury: a narrative review on current status and future challenges. Clin Kidney J. 2012;5(2):102–8.
207. Devarajan P. Biomarkers for the early detection of acute kidney injury. Curr Opin Pediatr. 2011;23(2):194–200.
208. Wasilewska A, Taranta-Janusz K, Debek W, Zoch-Zwierz W, Kuroczycka-Saniutycz E. KIM-1 and NGAL: new markers of obstructive nephropathy. Pediatr Nephrol. 2011;26(4):579–86.
209. Wei Q, Xiao X, Fogle P, Dong Z. Changes in metabolic profiles during acute kidney injury and recovery following ischemia/reperfusion. PloS One. 2014;9(9):e106647.
210. Iacovidou N, Syggelou A, Chalkias A, Atzori L, Xanthos T, Fanos V. Metabolomics applied in neonatology. Bioanalysis. 2014;6(3):403–10.
211. Syggelou A, Iacovidou N, Atzori L, Xanthos T, Fanos V. Metabolomics in the developing human being. Pediatr Clin North Am. 2012;59(5):1039–58.
212. Zhao YY, Lint RC. Metabolomics in nephrotoxicity. Adv Clin Chem. 2014;65:69–89.
213. Holzscheiter L, Beck C, Rutz S, Manuilova E, Domke I, Guder WG, et al. NGAL, L-FABP, and KIM-1 in comparison to established markers of renal dysfunction. Clin Chem Lab Med. 2014;52(4):537–46.
214. Fontanilla J, Han WK. Kidney injury molecule-1 as an early detection tool for acute kidney injury and other kidney diseases. Expert Opin Med Diagn. 2011;5(2):161–73.
215. Han WK, Bailly V, Abichandani R, Thadhani R, Bonventre JV. Kidney Injury Molecule-1 (KIM-1): a novel biomarker for human renal proximal tubule injury. Kidney Int. 2002;62(1):237–44.
216. Ronco C. N-GAL: diagnosing AKI as soon as possible. Crit Care. 2007;11(6):173.
217. Zappitelli M, Washburn KK, Arikan AA, Loftis L, Ma Q, Devarajan P, et al. Urine neutrophil gelatinase-associated lipocalin is an early marker of acute kidney injury in critically ill children: a prospective cohort study. Crit Care. 2007;11(4):R84.
218. Parikh CR, Jani A, Melnikov VY, Faubel S, Edelstein CL. Urinary interleukin-18 is a marker of human acute tubular necrosis. Am J Kidney Dis. 2004;43(3):405–14.
219. Wu H, Craft ML, Wang P, Wyburn KR, Chen G, Ma J, et al. IL-18 contributes to renal damage after ischemia-reperfusion. J Am Soc Nephrol. 2008;19(12):2331–41.
220. Yamamoto T, Noiri E, Ono Y, Doi K, Negishi K, Kamijo A, et al. Renal L-type fatty acid: binding protein in acute ischemic injury. J Am Soc Nephrol. 2007;18(11):2894–902.
221. Susantitaphong P, Siribamrungwong M, Doi K, Noiri E, Jaber BL. Performance of urinary liver-type fatty acid-binding protein in acute kidney injury: a meta-analysis. Am J Kidney Dis. 2013;61(3):430–9.
222. Meersch M, Schmidt C, Van Aken H, Martens S, Rossaint J, Singbartl K, et al. Urinary TIMP-2 and IGFBP7 as early biomarkers of acute kidney injury and renal recovery following cardiac surgery. PloS One. 2014;9(3):e93460.
223. Spanaus KS, Kollerits B, Ritz E, Hersberger M, Kronenberg F, von Eckardstein A. Serum creatinine, cystatin C, and beta-trace protein in diagnostic staging and predicting progression of primary nondiabetic chronic kidney disease. Clin Chem. 2010;56(5):740–9.
224. Bhavsar NA, Appel LJ, Kusek JW, Contreras G, Bakris G, Coresh J, et al. Comparison of measured GFR, serum creatinine, cystatin C, and beta-trace protein to predict ESRD in African Americans with hypertensive CKD. Am J Kidney Dis. 2011;58(6):886–93.
225. Kamijo A, Sugaya T, Hikawa A, Yamanouchi M, Hirata Y, Ishimitsu T, et al. Clinical evaluation of urinary excretion of liver-type fatty acid-binding protein as a marker for the monitoring of chronic kidney disease: a multicenter trial. J Lab Clin Med. 2005;145(3):125–33.
226. Hanai K, Babazono T, Nyumura I, Toya K, Tanaka N, Tanaka M, et al. Asymmetric dimethylarginine is closely associated with the development and progression of nephropathy in patients with type 2 diabetes. Nephrol Dial Transplant. 2009;24(6):1884–8.
227. Ravani P, Tripepi G, Malberti F, Testa S, Mallamaci F, Zoccali C. Asymmetrical dimethylarginine predicts progression to dialysis and death in patients with chronic kidney disease: a competing risks modeling approach. J Am Soc Nephrol. 2005;16(8):2449–55.
228. Naghibi B, Ghafghazi T, Hajhashemi V, Talebi A. Vancomycin-induced nephrotoxicity in rats: is enzyme elevation a consistent finding in tubular injury? J Nephrol. 2007;20(4):482–8.
229. Svendsen KB, Ellingsen T, Bech JN, Pfeiffer-Jensen M, Stengaard-Pedersen K, Pedersen EB. Urinary excretion of alpha-GST and albumin in rheumatoid arthritis patients treated with methotrexate or other DMARDs alone or in combination with NSAIDs. Scand J Rheumatol. 2005;34(1):34–9.
230. Harrison DJ, Kharbanda R, Cunningham DS, McLellan LI, Hayes JD. Distribution of glutathione S-transferase isoenzymes in human kidney: basis for possible markers of renal injury. J Clin Pathol. 1989;42(6):624–8.
231. Hanna MH, Segar JL, Teesch LM, Kasper DC, Schaefer FS, Brophy PD. Urinary metabolomic markers of aminoglycoside nephrotoxicity in newborn rats. Pediatr Res. 2013;73(5):585–91.
232. Ding W, Mak RH. Early markers of obesity-related renal injury in childhood. Pediatr Nephrol. 2015;30(1):1–4.
233. Fanos V, Van den Anker J, Noto A, Mussap M, Atzori L. Metabolomics in neonatology: fact or fiction? Semin Fetal Neonatal Med. 2013;18(1):3–12.
234. Pfister M, D’Argenio DZ. The emerging scientific discipline of pharmacometrics. J Clin Pharmacol. 2010;50(9 Suppl):6S.
235. van der Graaf PH. CPT: Pharmacometrics and Systems Pharmacology. CPT Pharmacometrics Syst Pharmacol. 2012;1:e8.
236. Mould DR, Upton RN. Basic concepts in population modeling, simulation, and model-based drug development. Part 2: introduction to pharmacokinetic modeling methods. CPT Pharmacometrics Syst Pharmacol. 2013;2:e38.
237. Sheiner LB. The population approach to pharmacokinetic data analysis: rationale and standard data analysis methods. Drug Metab Rev. 1984;15(1–2):153–71.
238. Wilbaux M, Henin E, Oza A, Colomban O, Pujade-Lauraine E, Freyer G, et al. Prediction of tumour response induced by chemotherapy using modelling of CA-125 kinetics in recurrent ovarian cancer patients. Br J Cancer. 2014;110(6):1517–24.
239. Wilbaux M, Henin E, Oza A, Colomban O, Pujade-Lauraine E, Freyer G, et al. Dynamic modeling in ovarian cancer: an original approach linking early changes in modeled longitudinal CA-125 kinetics and survival to help decisions in early drug development. Gynecol Oncol. 2014;133(3):460–6.
240. Zhang Y, Wei X, Bajaj G, Barrett JS, Meibohm B, Joshi A, et al. Challenges and considerations for development of therapeutic proteins in pediatric patients. J Clin Pharmacol. 2015;55(Suppl 3):S103–15.
241. Thomson AH, Whiting B. Bayesian parameter estimation and population pharmacokinetics. Clin Pharmacokinet. 1992;22(6):447–67.
242. Admiraal R, van Kesteren C, Boelens JJ, Bredius RG, Tibboel D, Knibbe CA. Towards evidence-based dosing regimens in children on the basis of population pharmacokinetic pharmacodynamic modelling. Arch Dis Child. 2014;99(3):267–72.
243. Barrett J. Pharmacometrics in pediatrics. In: Schmidt S, Derendorf H, editors. Applied pharmacometrics. Berlin: Springer; 2014. pp. 83–108.
244. Barrett JS. Paediatric models in motion: requirements for model-based decision support at the bedside. Br J Clin Pharmacol. 2015;79(1):85–96.
245. Zhao W, Leroux S, Jacqz-Aigrain E. Dosage individualization in children: integration of pharmacometrics in clinical practice. World J Pediatr. 2014;10(3):197–203.
246. Pfister M, Nolin TD, Arya V. Optimizing drug development and use in patients with kidney disease: opportunities, innovations, and challenges. J Clin Pharmacol. 2012;52(1 Suppl):4s–6s.
247. Nolin TD, Arya V, Sitar DS, Pfister M. Optimizing drug development and use in patients with kidney disease. J Clin Pharmacol. 2011;51(5):628–30.
248. Zhang L, Roy A, Pfister M. Pharmacometrics in chronic kidney disease. In: Schmidt S, Derendorf H, editors. Applied Pharmacometrics. Berlin: Springer; 2014. pp. 109–38.
249. Engle WA. American Academy of Pediatrics Committee on Fetus and Newborn. Age terminology during the perinatal period. Pediatrics. 2004;114(5):1362–4.
250. Mould DR, Upton RN. Basic concepts in population modeling, simulation, and model-based drug development. CPT Pharmacometrics Syst Pharmacol. 2012;1:e6.
251. Upton RN, Mould DR. Basic concepts in population modeling, simulation, and model-based drug development. Part 3: introduction to pharmacodynamic modeling methods. CPT Pharmacometrics Syst Pharmacol. 2014;3:e88.
252. Jones H, Rowland-Yeo K. Basic concepts in physiologically based pharmacokinetic modeling in drug discovery and development. CPT Pharmacometrics Syst Pharmacol. 2013;2:e63.
253. Achour B, Barber J, Rostami-Hodjegan A. Expression of hepatic drug-metabolizing cytochrome p450 enzymes and their intercorrelations: a meta-analysis. Drug Metab Dispos. 2014;42(8):1349–56.
254. Johnson TN, Salem F, Jamei M, Rostami-Hodjegan A. Prediction of voriconazole non-linear pharmacokinetics using a paediatric physiologically based pharmacokinetic modelling approach. Clin Pharmacokinet. 2015;54(5):567–8.
255. Zane NR, Thakker DR. A physiologically based pharmacokinetic model for voriconazole disposition predicts intestinal first-pass metabolism in children. Clin Pharmacokinet. 2014;53(12):1171–82.
256. Tortorici MA, Cutler D, Zhang L, Pfister M. Design, conduct, analysis, and interpretation of clinical studies in patients with impaired kidney function. J Clin Pharmacol. 2012;52(1 Suppl):109S–18S.
257. Zhang L, Pfister M, Meibohm B. Concepts and challenges in quantitative pharmacology and model-based drug development. AAPS J. 2008;10(4):552–9.
258. Zhang L, Xu N, Xiao S, Arya V, Zhao P, Lesko LJ, et al. Regulatory perspectives on designing pharmacokinetic studies and optimizing labeling recommendations for patients with chronic kidney disease. J Clin Pharmacol. 2012;52(1 Suppl):79S–90S.
259. Zhang L, Boulton DW, Pfister M. A pharmacometric approach to quantify the impact of chronic kidney disease and hemodialysis on systemic drug exposure: application to saxagliptin. J Clin Pharmacol. 2012;52(1 Suppl):126s–33s.
260. Meibohm B, Laer S, Panetta JC, Barrett JS. Population pharmacokinetic studies in pediatrics: issues in design and analysis. AAPS J. 2005;7(2):E475–87.
261. Barrett JS, Della Casa Alberighi O, Laer S, Meibohm B. Physiologically based pharmacokinetic (PBPK) modeling in children. Clin Pharmacol Ther. 2012;92(1):40–9.
262. Jadhav PR, Kern SE. The need for modeling and simulation to design clinical investigations in children. J Clin Pharmacol. 2010;50(9 Suppl):121S–9S.
263. Leong R, Vieira ML, Zhao P, Mulugeta Y, Lee CS, Huang SM, et al. Regulatory experience with physiologically based pharmacokinetic modeling for pediatric drug trials. Clin Pharmacol Ther. 2012;91(5):926–31.
264. Tod M, Jullien V, Pons G. Facilitation of drug evaluation in children by population methods and modelling. Clin Pharmacokinet. 2008;47(4):231–43.
265. Vong C, Bergstrand M, Nyberg J, Karlsson MO. Rapid sample size calculations for a defined likelihood ratio test-based power in mixed-effects models. AAPS J. 2012;14(2):176–86.
266. Ogungbenro K, Aarons L, Graham G. Sample size calculations based on generalized estimating equations for population pharmacokinetic experiments. J Biopharm Stat. 2006;16(2):135–50.
267. Maharaj AR, Edginton AN. Physiologically based pharmacokinetic modeling and simulation in pediatric drug development. CPT Pharmacometrics Syst Pharmacol. 2014;3:e150.
268. Emoto C, Fukuda T, Johnson TN, Adams DM, Vinks AA. Development of a pediatric physiologically based pharmacokinetic model for sirolimus: applying principles of growth and maturation in neonates and infants. CPT Pharmacometrics Syst Pharmacol. 2015;4:e17.
269. Jiang XL, Zhao P, Barrett JS, Lesko LJ, Schmidt S. Application of physiologically based pharmacokinetic modeling to predict acetaminophen metabolism and pharmacokinetics in children. CPT Pharmacometrics Syst Pharmacol. 2013;2:e80.
270. Yang F, Tong X, McCarver DG, Hines RN, Beard DA. Population-based analysis of methadone distribution and metabolism using an age-dependent physiologically based pharmacokinetic model. J Pharmacokinet Pharmacodyn. 2006;33(4):485–518.
271. Maharaj AR, Barrett JS, Edginton AN. A workflow example of PBPK modeling to support pediatric research and development: case study with lorazepam. AAPS J. 2013;15(2):455–64.
272. Bellanti F, Della Pasqua O. Modelling and simulation as research tools in paediatric drug development. Eur J Clin Pharmacol. 2011;67(Suppl 1):75–86.
273. Lee JY, Garnett CE, Gobburu JV, Bhattaram VA, Brar S, Earp JC, et al. Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008. Clin Pharmacokinet. 2011;50(10):627–35.
274. Manolis E, Osman TE, Herold R, Koenig F, Tomasi P, Vamvakas S, et al. Role of modeling and simulation in pediatric investigation plans. Paediatr Anaesth. 2011;21(3):214–21.
275. Hong Y, Kowalski KG, Zhang J, Zhu L, Horga M, Bertz R, et al. Model-based approach for optimization of atazanavir dose recommendations for HIV-infected pediatric patients. Antimicrob Agents Chemother. 2011;55(12):5746–52.
276. Booth BP, Rahman A, Dagher R, Griebel D, Lennon S, Fuller D, et al. Population pharmacokinetic-based dosing of intravenous busulfan in pediatric patients. J Clin Pharmacol. 2007;47(1):101–11.
277. Nguyen L. Integration of modelling and simulation into the development of intravenous busulfan in paediatrics: an industrial experience. Fundam Clin Pharmacol. 2008;22(6):599–604.
278. Li F, Nandy P, Chien S, Noel GJ, Tornoe CW. Pharmacometrics-based dose selection of levofloxacin as a treatment for postexposure inhalational anthrax in children. Antimicrob Agents Chemother. 2010;54(1):375–9.
279. Madabushi R, Cox DS, Hossain M, Boyle DA, Patel BR, Young G, et al. Pharmacokinetic and pharmacodynamic basis for effective argatroban dosing in pediatrics. J Clin Pharmacol. 2011;51(1):19–28.
280. Tornoe CW, Tworzyanski JJ, Imoisili MA, Alexander JJ, Korth-Bradley JM, Gobburu JV. Optimising piperacillin/tazobactam dosing in paediatrics. Int J Antimicrob Agents. 2007;30(4):320–4.
281. Yim DS, Zhou H, Buckwalter M, Nestorov I, Peck CC, Lee H. Population pharmacokinetic analysis and simulation of the time-concentration profile of etanercept in pediatric patients with juvenile rheumatoid arthritis. J Clin Pharmacol. 2005;45(3):246–56.
282. Landersdorfer CB, Bexon M, Edelman J, Rojavin M, Kirkpatrick CM, Lu J, et al. Pharmacokinetic modeling and simulation of biweekly subcutaneous immunoglobulin dosing in primary immunodeficiency. Postgrad Med. 2013;125(6):53–61.
283. Rojavin M, Sidhu J, Pfister M, Hubsch A. Subcutaneous immunoglobulin loading regimens for previously untreated patients with primary antibody deficiency. Clin Exp Immunol. 2014;178(Suppl 1):146–8.
284. Sidhu J, Rojavin M, Pfister M, Edelman J. Enhancing patient flexibility of subcutaneous immunoglobulin G dosing: pharmacokinetic outcomes of various maintenance and loading regimens in the treatment of primary immunodeficiency. Biol Ther. doi:10.1007/s13554-014-0018-0(Epub 14 Aug 2014).
285. Widmer N, Csajka C, Werner D, Grouzmann E, Decosterd LA, Eap CB, et al. Principles of therapeutic drug monitoring [in French]. Rev Med Suisse. 2008;4(165):1644–8.
286. Widmer N, Werner D, Grouzmann E, Eap CB, Marchetti O, Fayet A, et al. Therapeutic drug monitoring: clinical practice [in French]. Rev Med Suisse. 2008;4(165):1649–50, 1652–60.
287. Rousseau A, Marquet P. Application of pharmacokinetic modelling to the routine therapeutic drug monitoring of anticancer drugs. Fundam Clin Pharmacol. 2002;16(4):253–62.
288. Santini J, Milano G, Thyss A, Renee N, Viens P, Ayela P, et al. 5-FU therapeutic monitoring with dose adjustment leads to an improved therapeutic index in head and neck cancer. Br J Cancer. 1989;59(2):287–90.
289. Fuchs A, Csajka C, Thoma Y, Buclin T, Widmer N. Benchmarking therapeutic drug monitoring software: a review of available computer tools. Clin Pharmacokinet. 2013;52(1):9–22.
290. Fletcher CV, Brundage RC, Remmel RP, Page LM, Weller D, Calles NR, et al. Pharmacologic characteristics of indinavir, didanosine, and stavudine in human immunodeficiency virus-infected children receiving combination therapy. Antimicrob Agents Chemother. 2000;44(4):1029–34.
291. Grub S, Delora P, Ludin E, Duff F, Fletcher CV, Brundage RC, et al. Pharmacokinetics and pharmacodynamics of saquinavir in pediatric patients with human immunodeficiency virus infection. Clin Pharmacol Ther. 2002;71(3):122–30.
292. Soldin OP, Soldin SJ. Review: therapeutic drug monitoring in pediatrics. Ther Drug Monit. 2002;24(1):1–8.
293. Soldin SJ, Steele BW. Mini-review: therapeutic drug monitoring in pediatrics. Clin Biochem. 2000;33(5):333–5.
294. Pichini S, Papaseit E, Joya X, Vall O, Farre M, Garcia-Algar O, et al. Pharmacokinetics and therapeutic drug monitoring of psychotropic drugs in pediatrics. Ther Drug Monit. 2009;31(3):283–318.
295. Gotta V, Widmer N, Montemurro M, Leyvraz S, Haouala A, Decosterd LA, et al. Therapeutic drug monitoring of imatinib: Bayesian and alternative methods to predict trough levels. Clin Pharmacokinet. 2012;51(3):187–201.
296. Barker CI, Germovsek E, Hoare RL, Lestner JM, Lewis J, Standing JF. Pharmacokinetic/pharmacodynamic modelling approaches in paediatric infectious diseases and immunology. Adv Drug Deliv Rev. 2014;73:127–39.
297. Fissell R, Schulman G, Pfister M, Zhang L, Hung AM. Novel dialysis modalities: do we need new metrics to optimize treatment? J Clin Pharmacol. 2012;52(1 Suppl):72s–8s.
298. Marsenic O, Zhang L, Zuppa A, Barrett JS, Pfister M. Application of individualized Bayesian urea kinetic modeling to pediatric hemodialysis. ASAIO J. 2010;56(3):246–53.
299. Hariharan S, Madabushi R. Clinical pharmacology basis of deriving dosing recommendations for dabigatran in patients with severe renal impairment. J Clin Pharmacol. 2012;52(1 Suppl):119s–25s.
300. Leekha S, Terrell CL, Edson RS. General principles of antimicrobial therapy. Mayo Clin Proc. 2011;86(2):156–67.
301. Eagle H, Fleischman R, Musselman AD. Effect of schedule of administration on the therapeutic efficacy of penicillin; importance of the aggregate time penicillin remains at effectively bactericidal levels. Am J Med. 1950;9(3):280–99.
302. Edwards MS. Antibacterial therapy in pregnancy and neonates. Clin Perinatol. 1997;24(1):251–66.
303. Leroux S, Zhao W, Betremieux P, Pladys P, Saliba E, Jacqz-Aigrain E. Therapeutic guidelines for prescribing antibiotics in neonates should be evidence-based: a French national survey. Arch Dis Child. 2015;100(4):394–8.
304. van den Anker JN, Allegaert K. Pharmacokinetics of aminoglycosides in the newborn. Curr Pharm Des. 2012;18(21):3114–18.
305. Edson RS, Terrell CL. The aminoglycosides. Mayo Clin Proc. 1991;66(11):1158–64.
306. Karanwal AB, Parikh BJ, Goswami P, Panchal HP, Parekh BB, Patel KB. Review of clinical profile and bacterial spectrum and sensitivity patterns of pathogens in febrile neutropenic patients in hematological malignancies: a retrospective analysis from a single center. Indian J Med Paediatr Oncol. 2013;34(2):85–8.
307. Zhanel GG, Lawson CD, Zelenitsky S, Findlay B, Schweizer F, Adam H, et al. Comparison of the next-generation aminoglycoside plazomicin to gentamicin, tobramycin and amikacin. Expert Rev Anti Infect Ther. 2012;10(4):459–73.
308. Pacifici GM. Clinical pharmacokinetics of aminoglycosides in the neonate: a review. Eur J Clin Pharmacol. 2009;65(4):419–27.
309. van den Anker JN. How to optimize the evaluation and use of antibiotics in neonates. Early Hum Dev. 2014;90(Suppl 1):S10–2.
310. Setiabudy R, Suwento R, Rundjan L, Yasin FH, Louisa M, Dwijayanti A, et al. Lack of a relationship between the serum concentration of aminoglycosides and ototoxicity in neonates. Int J Clin Pharmacol Ther. 2013;51(5):401–6.
311. De Cock RF, Allegaert K, Schreuder MF, Sherwin CM, de Hoog M, van den Anker JN, et al. Maturation of the glomerular filtration rate in neonates, as reflected by amikacin clearance. Clin Pharmacokinet. 2012;51(2):105–17.
312. Abdel-Hady E, El Hamamsy M, Hedaya M, Awad H. The efficacy and toxicity of two dosing-regimens of amikacin in neonates with sepsis. J Clin Pharm Ther. 2011;36(1):45–52.
313. Schreuder MF, Wilhelm AJ, Bokenkamp A, Timmermans SM, Delemarre-van de Waal HA, van Wijk JA. Impact of gestational age and birth weight on amikacin clearance on day 1 of life. Clin J Am Soc Nephrol. 2009;4(11):1774–8.
314. Siddiqi A, Khan DA, Khan FA, Razzaq A. Therapeutic drug monitoring of amikacin in preterm and term infants. Singap Med J. 2009;50(5):486–9.
315. Sherwin CM, Svahn S, Van der Linden A, Broadbent RS, Medlicott NJ, Reith DM. Individualised dosing of amikacin in neonates: a pharmacokinetic/pharmacodynamic analysis. Eur J Clin Pharmacol. 2009;65(7):705–13.
316. Allegaert K, Cossey V, Debeer A, Langhendries JP, Van Overmeire B, de Hoon J, et al. The impact of ibuprofen on renal clearance in preterm infants is independent of the gestational age. Pediatr Nephrol. 2005;20(6):740–3.
317. Treluyer JM, Merle Y, Tonnelier S, Rey E, Pons G. Nonparametric population pharmacokinetic analysis of amikacin in neonates, infants, and children. Antimicrob Agents Chemother. 2002;46(5):1381–7.
318. Labaune JM, Bleyzac N, Maire P, Jelliffe RW, Boutroy MJ, Aulagner G, et al. Once-a-day individualized amikacin dosing for suspected infection at birth based on population pharmacokinetic models. Biol Neonate. 2001;80(2):142–7.
319. Wang J, Liang WQ, Wu JJ, Pan CM. Population pharmacokinetic analysis of amikacin and validation on neonates using Monte Carlo method. Acta Pharmacol Sin. 2000;21(10):954–60.
320. Langhendries JP, Battisti O, Bertrand JM, Francois A, Kalenga M, Darimont J, 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(5):351–62.
321. Botha JH, du Preez MJ, Miller R, Adhikari M. Determination of population pharmacokinetic parameters for amikacin in neonates using mixed-effect models. Eur J Clin Pharmacol. 1998;53(5):337–41.
322. Petersen PO, Wells TG, Kearns GL. Amikacin dosing in neonates: evaluation of a dosing chart based on population pharmacokinetic data. Dev Pharmacol Ther. 1991;16(4):203–11.
323. Kenyon CF, Knoppert DC, Lee SK, Vandenberghe HM, Chance GW. Amikacin pharmacokinetics and suggested dosage modifications for the preterm infant. Antimicrob Agents Chemother. 1990;34(2):265–8.
324. Allegaert K, Anderson BJ, Cossey V, Holford NH. Limited predictability of amikacin clearance in extreme premature neonates at birth. Br J Clin Pharmacol. 2006;61(1):39–48.
325. Sherwin CM, Wead S, Stockmann C, Healy D, Spigarelli MG, Neely A, et al. Amikacin population pharmacokinetics among paediatric burn patients. Burns. 2014;40(2):311–8.
326. Allegaert K. The impact of ibuprofen or indomethacin on renal drug clearance in neonates. J Matern Fetal Neonatal Med. 2009;22(Suppl 3):88–91.
327. Allegaert K, Cossey V, Langhendries JP, Naulaers G, Vanhole C, Devlieger H, et al. Effects of co-administration of ibuprofen-lysine on the pharmacokinetics of amikacin in preterm infants during the first days of life. Biol Neonate. 2004;86(3):207–11.
328. De Cock RF, Allegaert K, Sherwin CM, Nielsen EI, de Hoog M, van den Anker JN, et al. A neonatal amikacin covariate model can be used to predict ontogeny of other drugs eliminated through glomerular filtration in neonates. Pharm Res. 2014;31(3):754–67.
329. Jadhav PR, Zhang J, Gobburu JV. Leveraging prior quantitative knowledge in guiding pediatric drug development: a case study. Pharm Stat. 2009;8(3):216–24.
330. Bai JP, Barrett JS, Burckart GJ, Meibohm B, Sachs HC, Yao L. Strategic biomarkers for drug development in treating rare diseases and diseases in neonates and infants. AAPS J. 2013;15(2):447–54.
331. Harnisch L, Matthews I, Chard J, Karlsson MO. Drug and disease model resources: a consortium to create standards and tools to enhance model-based drug development. CPT Pharmacometrics Syst Pharmacol. 2013;2:e34.
332. Drug Disease Model Resources (DDMoRe). 2015. Availabel at: http://www.ddmore.eu/. Accessed 27 Feb 2015.
333. Bazzoli C, Retout S, Mentré F. Design evaluation and optimisation in multiple response nonlinear mixed effect models: PFIM 3.0. Comput Methods Programs Biomed. 2010;98(1):55–65.
334. Mentré F, Chenel M, Comets E, Grevel J, Hooker A, Karlsson MO, et al. Current use and developments needed for optimal design in pharmacometrics: a study performed among DDMoRe’s European Federation of Pharmaceutical Industries and Associations members. CPT Pharmacometrics Syst Pharmacol. 2013;2:e46.
335. Hennig S, Holthouse F, Staatz CE. Comparing dosage adjustment methods for once-daily tobramycin in paediatric and adolescent patients with cystic fibrosis. Clin Pharmacokinet. 2015;54(4):409–21.